A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01135511
Collaborator
(none)
285
27
5
9
10.6
1.2
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
285 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease
Study Start Date
:
Jul 1, 2010
Actual Primary Completion Date
:
Apr 1, 2011
Actual Study Completion Date
:
Apr 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment 1
|
Drug: CP-690,550 Eye drops
Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
|
| Experimental: Treatment 2
|
Drug: CP-690,550 Eye drops
Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks
|
| Experimental: Treatment 3
|
Drug: CP-690,550 Eye drops
Ophthalmic topical solution, high dose, dosed once/day, 8 weeks
|
| Placebo Comparator: Treatment 4
|
Drug: CP-690,550 Eye drops-vehicle
Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
|
| Active Comparator: Treatment 5
|
Drug: Sodium Hyaluronate
Ophthalmic topical solution, dosed 6 times/day, 8 weeks
|
Outcome Measures
Primary Outcome Measures
- Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 [Baseline, Week 8]
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Secondary Outcome Measures
- Changes in Corneal Staining Scores for Study Eye From Baseline [Baseline, Week 1, 2 and 4]
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
- Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye [Week 1, 2, 4 and 8]
Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline [Baseline, Week 1, 2, 4 and 8]
Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
- Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline [Baseline, Week 1, 2, 4 and 8]
TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
- Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline [Baseline, Week 1, 2, 4 and 8]
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
- Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye [Week 1, 2, 4 and 8]
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye [Week 1, 2, 4 and 8]
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Changes in the Ocular Comfort Index (OCI) Total Score From Baseline [Baseline, Week 1, 2, 4 and 8]
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
- Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline [Week 1, 2, 4 and 8]
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
- Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline [Baseline, Week 1, 2, 4 and 8]
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms [Baseline, Week 1, 2, 4 and 8]
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function [Baseline, Week 1, 2, 4 and 8]
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers [Baseline, Week 1, 2, 4 and 8]
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
- Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline [Week 1, 2, 4 and 8]
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye [Week 8]
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye [Week 8]
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores [Week 8]
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Number of Participants With Ocular Adverse Events (AEs)by Severity [8 weeks]
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
- Number of Participants With Nonocular Adverse Events (AEs) by Severity [8 weeks]
Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
- Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale [8 weeks]
Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Other Outcome Measures
- Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye [Baseline, Week 4 and 8]
The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline.
- Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye [Baseline, Week 4 and 8]
Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 [Week 4 and 8]
Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
- Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein [Baseline, Week 4 and 8]
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjective symptoms of dry eye for at least 6 months
-
Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)
Exclusion Criteria:
-
Women who are nursing, pregnant or planning pregnancy during the study
-
Participation in other studies within 30 days of screening visit
-
Ocular disorders that may confound interpretation of study results
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Ichinomiya | Aichi | Japan | |
| 2 | Pfizer Investigational Site | Narashino | Chiba | Japan | |
| 3 | Pfizer Investigational Site | Urayasu | Chiba | Japan | |
| 4 | Pfizer Investigational Site | Yokohama | Kanagawa | Japan | |
| 5 | Pfizer Investigational Site | Yokohama | Kangawa | Japan | |
| 6 | Pfizer Investigational Site | Fuji | Shizuoka | Japan | |
| 7 | Pfizer Investigational Site | Numazu | Shizuoka | Japan | |
| 8 | Pfizer Investigational Site | Susono | Shizuoka | Japan | |
| 9 | Pfizer Investigational Site | Chiyoda-ku | Tokyo | Japan | |
| 10 | Pfizer Investigational Site | Hamura | Tokyo | Japan | |
| 11 | Pfizer Investigational Site | Minato-ku | Tokyo | Japan | |
| 12 | Pfizer Investigational Site | Ohta-ku | Tokyo | Japan | |
| 13 | Pfizer Investigational Site | Sumida-ku | Tokyo | Japan | |
| 14 | Pfizer Investigational Site | Tachikawa | Tokyo | Japan | |
| 15 | Pfizer Investigational Site | Taito-ku | Tokyo | Japan | |
| 16 | Pfizer Investigational Site | Chiba | Japan | ||
| 17 | Pfizer Investigational Site | Fukuoka | Japan | ||
| 18 | Pfizer Investigational Site | Kyoto | Japan | ||
| 19 | Pfizer Investigational Site | Osaka | Japan | ||
| 20 | Pfizer Investigational Site | Shizuoka | Japan | ||
| 21 | Pfizer Investigational Site | Tokyo | Japan | ||
| 22 | Pfizer Investigational Site | Gwangju | Korea, Republic of | 501-757 | |
| 23 | Pfizer Investigational Site | Seoul | Korea, Republic of | 110-744 | |
| 24 | Pfizer Investigational Site | Seoul | Korea, Republic of | 120-752 | |
| 25 | Pfizer Investigational Site | Seoul | Korea, Republic of | 136-705 | |
| 26 | Pfizer Investigational Site | Seoul | Korea, Republic of | 137-701 | |
| 27 | Pfizer Investigational Site | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01135511
Other Study ID Numbers:
- A3921072
First Posted:
Jun 2, 2010
Last Update Posted:
May 7, 2013
Last Verified:
Mar 1, 2013
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | In this study, during the 2-week run-in period, enrolled participants were administered artificial tears 4 times daily after signing informed consent. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| Period Title: Overall Study | |||||||||
| STARTED | 41 | 42 | 41 | 40 | 39 | 21 | 19 | 21 | 21 |
| COMPLETED | 41 | 39 | 33 | 37 | 38 | 20 | 18 | 20 | 20 |
| NOT COMPLETED | 0 | 3 | 8 | 3 | 1 | 1 | 1 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | Total of all reporting groups |
| Overall Participants | 41 | 42 | 41 | 40 | 39 | 21 | 19 | 21 | 21 | 285 |
| Age, Customized (participants) [Number] | ||||||||||
| Between 18 and 44 years |
14
34.1%
|
14
33.3%
|
11
26.8%
|
11
27.5%
|
11
28.2%
|
5
23.8%
|
8
42.1%
|
7
33.3%
|
3
14.3%
|
84
29.5%
|
| Between 45 and 64 years |
9
22%
|
14
33.3%
|
12
29.3%
|
16
40%
|
14
35.9%
|
10
47.6%
|
8
42.1%
|
13
61.9%
|
10
47.6%
|
106
37.2%
|
| >=65 years |
18
43.9%
|
14
33.3%
|
18
43.9%
|
13
32.5%
|
14
35.9%
|
6
28.6%
|
3
15.8%
|
1
4.8%
|
8
38.1%
|
95
33.3%
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
32
78%
|
39
92.9%
|
37
90.2%
|
33
82.5%
|
34
87.2%
|
20
95.2%
|
16
84.2%
|
20
95.2%
|
19
90.5%
|
250
87.7%
|
| Male |
9
22%
|
3
7.1%
|
4
9.8%
|
7
17.5%
|
5
12.8%
|
1
4.8%
|
3
15.8%
|
1
4.8%
|
2
9.5%
|
35
12.3%
|
Outcome Measures
| Title | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 |
|---|---|
| Description | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Baseline, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 | 21 | 19 | 21 | 21 |
| Mean (Standard Deviation) [Units on a scale] |
-3.0
(2.1)
|
-3.0
(2.8)
|
-3.0
(2.5)
|
-3.1
(2.6)
|
-3.2
(2.4)
|
-2.4
(2.4)
|
-3.0
(2.7)
|
-2.8
(1.9)
|
-2.2
(2.5)
|
| Title | Changes in Corneal Staining Scores for Study Eye From Baseline |
|---|---|
| Description | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2 and 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 |
-2.1
(1.9)
|
-1.9
(2.1)
|
-1.9
(2.1)
|
-1.6
(2.0)
|
-2.0
(2.0)
|
| Week 2 |
-2.4
(1.8)
|
-2.4
(2.0)
|
-3.2
(1.8)
|
-3.0
(2.0)
|
-2.8
(2.1)
|
| Week 4 |
-2.7
(2.0)
|
-3.0
(2.7)
|
-3.2
(2.4)
|
-3.3
(2.5)
|
-2.6
(2.1)
|
| Title | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye |
|---|---|
| Description | Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
4.9
12%
|
2.4
5.7%
|
5.0
12.2%
|
0
0%
|
0
0%
|
| Week 2 (n=40, 41, 39, 40, 39) |
2.5
6.1%
|
2.4
5.7%
|
5.1
12.4%
|
7.5
18.8%
|
2.6
6.7%
|
| Week 4 (n=41, 40, 35, 40, 38) |
12.2
29.8%
|
5.0
11.9%
|
8.6
21%
|
7.5
18.8%
|
2.6
6.7%
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
12.2
29.8%
|
4.9
11.7%
|
7.5
18.3%
|
7.5
18.8%
|
0
0%
|
| Title | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline |
|---|---|
| Description | Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
-0.8
(1.9)
|
-0.7
(1.8)
|
-0.6
(1.3)
|
-1.1
(1.7)
|
-0.6
(1.7)
|
| Week 2 (n=40, 41, 39, 40, 39) |
-1.0
(2.2)
|
-0.8
(2.0)
|
-0.7
(1.5)
|
-1.7
(2.5)
|
-1.0
(2.1)
|
| Week 4 (n=41, 40, 35, 40, 38) |
-1.2
(2.2)
|
-1.0
(1.7)
|
-0.8
(1.5)
|
-2.0
(2.4)
|
-1.1
(2.2)
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
-1.0
(2.3)
|
-1.1
(2.1)
|
-0.9
(1.4)
|
-2.0
(2.1)
|
-0.9
(1.8)
|
| Title | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline |
|---|---|
| Description | TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
0.04
(0.83)
|
0.43
(3.61)
|
0.19
(0.76)
|
0.22
(1.95)
|
0.43
(3.22)
|
| Week 2 (n=40, 41, 39, 40, 39) |
0.09
(0.95)
|
-0.31
(2.84)
|
0.26
(0.84)
|
0.04
(1.54)
|
1.72
(8.53)
|
| Week 4 (n=41, 40, 35, 40, 38) |
-0.01
(0.92)
|
0.20
(3.61)
|
0.31
(0.62)
|
0.46
(1.87)
|
0.53
(1.42)
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
-0.06
(1.13)
|
-0.25
(2.17)
|
0.27
(0.77)
|
1.00
(3.56)
|
0.76
(1.38)
|
| Title | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline |
|---|---|
| Description | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
0.78
(6.07)
|
0.34
(3.10)
|
0.01
(2.16)
|
0.08
(3.01)
|
0.71
(3.99)
|
| Week 2 (n=40, 41, 39, 40, 39) |
0.28
(2.77)
|
0.51
(3.49)
|
0.28
(2.26)
|
0.93
(3.56)
|
1.04
(4.53)
|
| Week 4 (n=41, 40, 35, 40, 38) |
0.30
(3.39)
|
0.49
(2.54)
|
0.13
(2.28)
|
1.13
(4.23)
|
0.64
(3.38)
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
0.91
(5.43)
|
0.10
(2.57)
|
0.74
(2.46)
|
0.26
(2.93)
|
1.53
(5.32)
|
| Title | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye |
|---|---|
| Description | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
7.3
17.8%
|
4.9
11.7%
|
0
0%
|
2.5
6.3%
|
7.7
19.7%
|
| Week 2 (n=40, 41, 39, 40, 39) |
2.5
6.1%
|
4.9
11.7%
|
2.6
6.3%
|
7.5
18.8%
|
10.3
26.4%
|
| Week 4 (n=41, 40, 35, 40, 38) |
7.3
17.8%
|
5.0
11.9%
|
2.9
7.1%
|
7.5
18.8%
|
5.3
13.6%
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
9.8
23.9%
|
4.9
11.7%
|
2.5
6.1%
|
5.0
12.5%
|
12.8
32.8%
|
| Title | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye |
|---|---|
| Description | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
2
4.9%
|
1
2.4%
|
0
0%
|
1
2.5%
|
1
2.6%
|
| Week 2 (n=40, 41, 39, 40, 39) |
0
0%
|
1
2.4%
|
0
0%
|
2
5%
|
2
5.1%
|
| Week 4 (n=41, 40, 35, 40, 38) |
1
2.4%
|
0
0%
|
0
0%
|
2
5%
|
1
2.6%
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
3
7.3%
|
0
0%
|
0
0%
|
1
2.5%
|
3
7.7%
|
| Title | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline |
|---|---|
| Description | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
-1.94
(5.20)
|
-2.00
(6.22)
|
-2.13
(7.92)
|
-4.17
(6.86)
|
-3.14
(7.88)
|
| Week 2 (n=40, 41, 40, 40, 39) |
-4.16
(9.00)
|
-4.76
(7.63)
|
-3.80
(8.77)
|
-5.88
(6.98)
|
-3.40
(6.12)
|
| Week 4 (n=41, 40, 35, 40, 38) |
-3.27
(6.95)
|
-4.20
(7.08)
|
-5.77
(9.71)
|
-5.74
(7.26)
|
-3.58
(9.85)
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
-5.09
(7.74)
|
-4.98
(7.67)
|
-3.90
(9.30)
|
-6.87
(8.59)
|
-4.22
(9.53)
|
| Title | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline |
|---|---|
| Description | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
17
41.5%
|
15
35.7%
|
13
31.7%
|
21
52.5%
|
16
41%
|
| Week 2 (n=40, 41, 40, 40, 39) |
19
46.3%
|
21
50%
|
19
46.3%
|
28
70%
|
20
51.3%
|
| Week 4 (n=41, 40, 35, 40, 38) |
23
56.1%
|
23
54.8%
|
21
51.2%
|
26
65%
|
16
41%
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
25
61%
|
26
61.9%
|
22
53.7%
|
26
65%
|
16
41%
|
| Title | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline |
|---|---|
| Description | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
-0.43
(12.33)
|
-3.87
(12.42)
|
-0.67
(12.68)
|
-5.00
(9.13)
|
-2.99
(10.27)
|
| Week 2 (n=40, 41, 40, 40, 39) |
-4.09
(13.73)
|
-7.04
(12.98)
|
-3.13
(14.45)
|
-6.77
(11.28)
|
-2.89
(11.34)
|
| Week 4 (n=41, 40, 35, 40, 38) |
-3.18
(13.77)
|
-5.99
(15.78)
|
-4.48
(13.92)
|
-5.11
(14.03)
|
-2.56
(12.69)
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
-3.88
(14.92)
|
-7.07
(17.88)
|
-0.37
(16.77)
|
-5.89
(14.98)
|
-2.68
(15.10)
|
| Title | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms |
|---|---|
| Description | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
-0.81
(15.90)
|
-4.07
(13.83)
|
-3.96
(13.74)
|
-5.00
(12.77)
|
-2.56
(14.70)
|
| Week 2 (n=40, 41, 40, 40, 39) |
-4.17
(19.61)
|
-8.74
(18.06)
|
-3.75
(14.24)
|
-7.92
(16.01)
|
-3.63
(13.49)
|
| Week 4 (n=41, 40, 35, 40, 38) |
-3.05
(18.89)
|
-7.50
(19.59)
|
-6.19
(14.05)
|
-5.42
(17.56)
|
-1.97
(15.43)
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
-3.86
(19.01)
|
-7.72
(21.20)
|
-2.29
(17.29)
|
-6.04
(18.87)
|
-0.21
(15.59)
|
| Title | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function |
|---|---|
| Description | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
-0.36
(18.75)
|
-4.71
(14.31)
|
0.40
(17.35)
|
-6.55
(12.20)
|
-3.33
(13.41)
|
| Week 2 (n=40, 41, 40, 40, 39) |
-2.61
(16.88)
|
-5.83
(15.52)
|
-2.29
(20.91)
|
-7.06
(11.87)
|
-2.57
(14.48)
|
| Week 4 (n=41, 40, 35, 40, 38) |
-1.70
(16.73)
|
-6.52
(15.25)
|
-4.74
(17.82)
|
-4.29
(14.04)
|
-2.69
(15.35)
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
-2.56
(19.45)
|
-8.29
(16.61)
|
-2.07
(18.71)
|
-4.75
(12.49)
|
-3.81
(17.46)
|
| Title | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers |
|---|---|
| Description | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Time Frame | Baseline, Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=38, 37, 40, 39, 35) |
1.21
(22.11)
|
-4.28
(23.66)
|
0.31
(22.20)
|
-3.53
(15.52)
|
-4.88
(20.32)
|
| Week 2 (n=37, 37, 39, 37, 37) |
-6.53
(20.43)
|
-7.21
(25.43)
|
-6.20
(22.25)
|
-8.56
(18.66)
|
-4.28
(21.48)
|
| Week 4 (n=38, 37, 35, 37, 36) |
-6.14
(23.72)
|
-3.15
(30.23)
|
-2.14
(24.88)
|
-9.57
(22.78)
|
-4.17
(23.44)
|
| Week 8 (n=38, 37, 40, 39, 38, LOCF) |
-7.13
(22.92)
|
-4.05
(34.11)
|
3.02
(31.76)
|
-8.44
(27.83)
|
-4.82
(24.46)
|
| Title | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline |
|---|---|
| Description | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Week 1, 2, 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Week 1 (n=41, 41, 40, 40, 39) |
14.6
35.6%
|
24.4
58.1%
|
12.5
30.5%
|
22.5
56.3%
|
20.5
52.6%
|
| Week 2 (n=40, 41, 40, 40, 39) |
32.5
79.3%
|
34.1
81.2%
|
27.5
67.1%
|
25.0
62.5%
|
20.5
52.6%
|
| Week 4 (n=41, 40, 35, 40, 38) |
34.1
83.2%
|
37.5
89.3%
|
25.7
62.7%
|
35.0
87.5%
|
18.4
47.2%
|
| Week 8 (n=41, 41, 40, 40, 39, LOCF) |
34.1
83.2%
|
41.5
98.8%
|
22.5
54.9%
|
35.0
87.5%
|
20.5
52.6%
|
| Title | Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye |
|---|---|
| Description | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Number [Participants] |
8
19.5%
|
4
9.5%
|
6
14.6%
|
5
12.5%
|
1
2.6%
|
| Title | Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye |
|---|---|
| Description | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Number [Participants] |
8
19.5%
|
6
14.3%
|
2
4.9%
|
4
10%
|
7
17.9%
|
| Title | Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores |
|---|---|
| Description | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population: Participants who received at least 1 dose of study treatment. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 |
| Number [Participants] |
31
75.6%
|
29
69%
|
30
73.2%
|
35
87.5%
|
28
71.8%
|
| Title | Number of Participants With Ocular Adverse Events (AEs)by Severity |
|---|---|
| Description | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: Participants who received at least 1 dose of study treatment. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 | 21 | 19 | 21 | 21 |
| Mild |
4
9.8%
|
0
0%
|
4
9.8%
|
2
5%
|
2
5.1%
|
3
14.3%
|
7
36.8%
|
0
0%
|
6
28.6%
|
| Moderate |
0
0%
|
0
0%
|
1
2.4%
|
0
0%
|
0
0%
|
2
9.5%
|
3
15.8%
|
6
28.6%
|
4
19%
|
| Severe |
0
0%
|
1
2.4%
|
2
4.9%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
9.5%
|
0
0%
|
| Title | Number of Participants With Nonocular Adverse Events (AEs) by Severity |
|---|---|
| Description | Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: Participants who received at least 1 dose of study treatment. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 | 21 | 19 | 21 | 21 |
| Mild |
7
17.1%
|
12
28.6%
|
10
24.4%
|
10
25%
|
8
20.5%
|
2
9.5%
|
1
5.3%
|
5
23.8%
|
4
19%
|
| Moderate |
1
2.4%
|
0
0%
|
2
4.9%
|
0
0%
|
0
0%
|
3
14.3%
|
1
5.3%
|
4
19%
|
2
9.5%
|
| Severe |
0
0%
|
0
0%
|
2
4.9%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale |
|---|---|
| Description | Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: Participants who received at least 1 dose of study treatment. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. |
| Measure Participants | 41 | 42 | 41 | 40 | 39 | 21 | 19 | 21 | 21 |
| None for blurring of vision |
32
78%
|
33
78.6%
|
32
78%
|
32
80%
|
36
92.3%
|
11
52.4%
|
11
57.9%
|
15
71.4%
|
13
61.9%
|
| Minor for blurring of vision |
9
22%
|
8
19%
|
7
17.1%
|
8
20%
|
3
7.7%
|
9
42.9%
|
6
31.6%
|
5
23.8%
|
7
33.3%
|
| Moderate for blurring of vision |
0
0%
|
1
2.4%
|
2
4.9%
|
0
0%
|
0
0%
|
1
4.8%
|
2
10.5%
|
1
4.8%
|
1
4.8%
|
| Severe for blurring of vision |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| None for burning sensation |
26
63.4%
|
22
52.4%
|
26
63.4%
|
27
67.5%
|
34
87.2%
|
7
33.3%
|
7
36.8%
|
11
52.4%
|
9
42.9%
|
| Minor for burning sensation |
15
36.6%
|
19
45.2%
|
14
34.1%
|
12
30%
|
4
10.3%
|
10
47.6%
|
10
52.6%
|
9
42.9%
|
10
47.6%
|
| Moderate for burning sensation |
0
0%
|
0
0%
|
1
2.4%
|
1
2.5%
|
0
0%
|
3
14.3%
|
2
10.5%
|
1
4.8%
|
2
9.5%
|
| Severe for burning sensation |
0
0%
|
1
2.4%
|
0
0%
|
0
0%
|
1
2.6%
|
1
4.8%
|
0
0%
|
0
0%
|
0
0%
|
| None for ocular discomfort |
30
73.2%
|
29
69%
|
30
73.2%
|
31
77.5%
|
29
74.4%
|
6
28.6%
|
4
21.1%
|
7
33.3%
|
6
28.6%
|
| Minor for ocular discomfort |
10
24.4%
|
12
28.6%
|
9
22%
|
8
20%
|
8
20.5%
|
8
38.1%
|
11
57.9%
|
6
28.6%
|
8
38.1%
|
| Moderate for ocular discomfort |
1
2.4%
|
1
2.4%
|
2
4.9%
|
1
2.5%
|
1
2.6%
|
6
28.6%
|
3
15.8%
|
7
33.3%
|
6
28.6%
|
| Severe for ocular discomfort |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.6%
|
1
4.8%
|
1
5.3%
|
1
4.8%
|
1
4.8%
|
| None for pain |
28
68.3%
|
30
71.4%
|
34
82.9%
|
32
80%
|
34
87.2%
|
12
57.1%
|
9
47.4%
|
12
57.1%
|
9
42.9%
|
| Minor for pain |
13
31.7%
|
11
26.2%
|
6
14.6%
|
7
17.5%
|
3
7.7%
|
4
19%
|
10
52.6%
|
7
33.3%
|
9
42.9%
|
| Moderate for pain |
0
0%
|
0
0%
|
1
2.4%
|
1
2.5%
|
2
5.1%
|
4
19%
|
0
0%
|
2
9.5%
|
3
14.3%
|
| Severe for pain |
0
0%
|
1
2.4%
|
0
0%
|
0
0%
|
0
0%
|
1
4.8%
|
0
0%
|
0
0%
|
0
0%
|
| None for tearing |
40
97.6%
|
38
90.5%
|
39
95.1%
|
37
92.5%
|
36
92.3%
|
15
71.4%
|
15
78.9%
|
18
85.7%
|
19
90.5%
|
| Minor for tearing |
1
2.4%
|
3
7.1%
|
2
4.9%
|
3
7.5%
|
3
7.7%
|
6
28.6%
|
4
21.1%
|
3
14.3%
|
2
9.5%
|
| Moderate for tearing |
0
0%
|
1
2.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Severe for tearing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye |
|---|---|
| Description | The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 8 | 5 | 10 | 12 | 13 |
| Week 4 (n=7, 4, 9, 12, 8) |
1570.4
(8698.5)
|
-13899.5
(13383.8)
|
5394.3
(10641.9)
|
1573.8
(10087.5)
|
-1908.6
(11259.4)
|
| Week 8 (n=6, 4, 6, 11, 10) |
-1496.5
(10426.5)
|
-8326.3
(11164.6)
|
56.0
(5308.4)
|
3431.9
(16532.5)
|
1148.5
(12129.6)
|
| Title | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye |
|---|---|
| Description | Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 8 | 5 | 10 | 12 | 13 |
| Week 4 (n=7, 4, 9, 12, 8) |
-10.27
(20.73)
|
-0.87
(18.24)
|
11.51
(18.74)
|
-6.83
(28.64)
|
18.30
(30.40)
|
| Week 8 (n=6, 4, 6, 11, 10) |
-6.77
(18.19)
|
6.65
(25.65)
|
5.17
(24.73)
|
-1.05
(35.75)
|
11.74
(24.84)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
-30.675
(78.363)
|
-38.540
(93.153)
|
-153.500
(164.756)
|
-6384.063
(12606.637)
|
58.500
(59.729)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-39.250
(786.061)
|
-5.167
(33.983)
|
-70.800
(16.688)
|
-5102.010
(11352.752)
|
-1.300
(1.752)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
247.5
(374.7)
|
-73.0
(57.6)
|
146.0
(206.5)
|
-154.6
(287.3)
|
22.5
(57.1)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-81.3
(110.7)
|
-6.0
(186.1)
|
100.0
(43.8)
|
18.0
(210.9)
|
51.2
(27.0)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
76.00
(140.92)
|
-36.80
(48.75)
|
22.50
(21.92)
|
-19.70
(126.34)
|
16.33
(34.70)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-11.00
(23.35)
|
4.00
(25.49)
|
139.00
(192.33)
|
25.80
(141.39)
|
12.00
(14.00)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
35.8
(51.6)
|
-6.8
(38.8)
|
28.0
(22.6)
|
3.5
(73.6)
|
10.0
(50.7)
|
| Week 8 (n=4, 6, 2, 5, 3) |
14.3
(16.7)
|
19.5
(30.9)
|
-15.0
(8.5)
|
-16.4
(28.6)
|
25.0
(16.5)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
365.0
(348.2)
|
-18.8
(739.1)
|
-7.0
(470.9)
|
-1057.3
(1954.2)
|
564.3
(1171.8)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-2486.3
(4656.3)
|
-367.8
(961.9)
|
-112.5
(484.4)
|
-471.6
(2378.4)
|
305.7
(361.9)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
-168.5
(265.3)
|
-438.8
(962.4)
|
24.5
(79.9)
|
-468.0
(390.6)
|
26.7
(63.1)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-179.3
(144.1)
|
-289.7
(1205.3)
|
-169.5
(217.1)
|
28.2
(431.0)
|
-14.3
(33.9)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
-5.0
(16.1)
|
-5.4
(17.0)
|
27.0
(14.1)
|
-17.0
(24.9)
|
3.7
(22.7)
|
| Week 8 (n=4, 6, 2, 5, 3) |
17.5
(21.7)
|
15.8
(57.9)
|
0.0
(0.0)
|
1.6
(38.4)
|
31.7
(23.6)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
-0.05
(1.60)
|
-1.42
(5.22)
|
2.75
(0.35)
|
-4.93
(10.29)
|
6.03
(8.54)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-0.70
(4.97)
|
-0.42
(5.84)
|
6.00
(8.49)
|
-2.14
(7.88)
|
2.03
(0.15)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=3, 5, 2, 4, 3) |
76500.0
(363953.6)
|
-172800.0
(256165.4)
|
269500.0
(498510.3)
|
-370575.0
(647507.1)
|
15600.0
(156124.6)
|
| Week 8 (n=4, 6, 2, 5, 2) |
-256000.0
(451986.0)
|
153833.3
(317150.7)
|
200000.0
(144249.8)
|
-268260.0
(546901.3)
|
397550.0
(621476.1)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
3.15
(6.14)
|
-13.80
(22.14)
|
8.00
(21.21)
|
-7.13
(19.21)
|
2.73
(3.04)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-6.78
(18.62)
|
3.60
(16.65)
|
-4.00
(9.90)
|
0.60
(6.02)
|
0.00
(0.00)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
2.675
(5.952)
|
-1.948
(3.682)
|
-0.470
(1.598)
|
-24.833
(48.019)
|
0.957
(1.202)
|
| Week 8 (n=4, 6, 2, 5, 3) |
21.205
(42.696)
|
-0.517
(3.527)
|
-0.650
(0.919)
|
-14.476
(31.070)
|
0.203
(0.313)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
22.3
(35.8)
|
-13.2
(29.5)
|
8.5
(12.0)
|
-88.3
(120.8)
|
35.0
(60.6)
|
| Week 8 (n=4, 6, 2, 5, 3) |
0.0
(0.0)
|
57.0
(90.1)
|
37.5
(53.0)
|
-41.2
(46.7)
|
26.7
(69.0)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
152.5
(1620.5)
|
-942.0
(2466.2)
|
840.0
(735.4)
|
-1486.5
(4486.5)
|
546.7
(546.4)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-1812.5
(1477.6)
|
790.0
(1639.2)
|
-910.0
(2588.0)
|
734.0
(3267.6)
|
-699.3
(1094.8)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
-1115.0
(3226.2)
|
-4054.0
(8558.2)
|
1535.0
(2170.8)
|
-628.5
(5314.7)
|
5400.0
(3104.5)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-2902.5
(4534.4)
|
505.0
(2977.2)
|
-1375.0
(1944.5)
|
1220.8
(4111.8)
|
2246.7
(2329.9)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
1.98
(5.47)
|
-2.08
(4.28)
|
1.95
(2.76)
|
-4.30
(9.40)
|
1.60
(1.44)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-1.18
(1.39)
|
0.88
(4.75)
|
0.00
(0.00)
|
-3.58
(8.01)
|
3.93
(4.61)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=3, 5, 2, 4, 3) |
-1196.7
(3885.1)
|
-7224.0
(27315.6)
|
14545.0
(24967.9)
|
-11622.5
(28687.6)
|
15103.3
(56584.3)
|
| Week 8 (n=4, 6, 2, 5, 2) |
-13440.0
(27749.2)
|
18971.7
(30883.3)
|
-6230.0
(7028.6)
|
6306.0
(24845.5)
|
-9690.0
(13732.0)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=3, 4, 2, 4, 3) |
-633.3
(1325.5)
|
-47485.0
(110811.6)
|
21025.0
(45078.1)
|
-18020.0
(44942.7)
|
14003.3
(22925.3)
|
| Week 8 (n=4, 5, 2, 5, 2) |
-34722.5
(62344.4)
|
3118.0
(23681.2)
|
-10150.0
(2899.1)
|
22148.0
(36704.1)
|
-4220.0
(5741.7)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
1.3
(541.7)
|
47.4
(281.2)
|
630.0
(325.3)
|
-1562.5
(2787.4)
|
-301.3
(1138.3)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-1237.8
(1975.3)
|
534.5
(868.9)
|
-360.0
(1004.1)
|
-327.6
(2083.1)
|
246.7
(331.6)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
13.25
(31.28)
|
-12.06
(70.14)
|
21.50
(40.31)
|
-28.98
(57.50)
|
19.43
(51.60)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-61.48
(79.46)
|
-3.83
(81.17)
|
6.50
(36.06)
|
-9.58
(49.45)
|
-8.93
(15.77)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
12.5
(85.9)
|
-19.8
(73.5)
|
124.5
(173.2)
|
-131.8
(165.9)
|
142.3
(375.9)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-48.5
(69.8)
|
34.3
(75.2)
|
-109.0
(168.3)
|
-76.8
(88.1)
|
114.0
(167.7)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
-0.5
(495.3)
|
-213.2
(1803.5)
|
-138.5
(186.0)
|
0.5
(3816.2)
|
-121.7
(1815.2)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-15.5
(370.2)
|
361.0
(857.7)
|
-885.0
(1322.3)
|
-122.0
(1612.5)
|
-212.7
(532.5)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
-228.00
(409.55)
|
-28.20
(94.15)
|
42.50
(181.73)
|
111.75
(293.07)
|
164.67
(73.04)
|
| Week 8 (n=4, 6, 2, 5, 3) |
99.50
(354.15)
|
125.17
(292.09)
|
1.00
(147.08)
|
96.00
(141.26)
|
81.33
(75.63)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=3, 5, 2, 4, 3) |
1704.00
(4222.07)
|
-871.40
(4857.15)
|
383.00
(24.04)
|
-35221.50
(67264.76)
|
1651.67
(7544.36)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-18222.00
(32490.62)
|
487.83
(5164.47)
|
6926.00
(10004.15)
|
-35105.40
(84919.27)
|
-1698.33
(2346.05)
|
| Title | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 |
|---|---|
| Description | Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Time Frame | Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 |
2
4.9%
|
2
4.8%
|
1
2.4%
|
1
2.5%
|
1
2.6%
|
| Week 8 |
0
0%
|
2
4.8%
|
1
2.4%
|
1
2.5%
|
1
2.6%
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
44.8
(337.3)
|
-228.6
(1493.7)
|
-41.0
(312.5)
|
-648.5
(1710.9)
|
130.0
(178.0)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-487.3
(364.0)
|
4.0
(910.5)
|
265.5
(685.2)
|
-427.6
(1479.9)
|
-289.3
(86.8)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
41.0
(35.6)
|
194.8
(428.5)
|
79.5
(89.8)
|
-328.5
(634.9)
|
-5.3
(23.5)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-97.0
(183.0)
|
33.5
(124.2)
|
30.5
(57.3)
|
-80.2
(200.1)
|
-15.3
(23.2)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
-17.00
(2539.88)
|
257.00
(382.18)
|
-3115.50
(4418.71)
|
-651.00
(659.50)
|
573.00
(8434.01)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-1524.50
(2083.82)
|
588.67
(1504.14)
|
-3560.00
(5048.74)
|
222.60
(1420.46)
|
-417.00
(4540.91)
|
| Title | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein |
|---|---|
| Description | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Time Frame | Baseline, Week 4 and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing. |
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. |
| Measure Participants | 17 | 14 | 9 | 8 | 11 |
| Week 4 (n=4, 5, 2, 4, 3) |
748.8
(4116.3)
|
-956.0
(4190.6)
|
1180.0
(311.1)
|
-8281.3
(13425.6)
|
6328.3
(17461.8)
|
| Week 8 (n=4, 6, 2, 5, 3) |
-2322.5
(4827.1)
|
836.7
(4104.5)
|
-5695.0
(8605.5)
|
-3070.0
(4798.4)
|
5195.0
(9724.4)
|
Adverse Events
| Time Frame | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||||||||||||||
| Arm/Group Title | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea | |||||||||
| Arm/Group Description | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | |||||||||
All Cause Mortality |
||||||||||||||||||
| CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | 0/42 (0%) | 2/41 (4.9%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Gastric ulcer | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Bronchiectasis | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Foot fracture | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/41 (26.8%) | 11/42 (26.2%) | 16/41 (39%) | 8/40 (20%) | 9/39 (23.1%) | 6/21 (28.6%) | 7/19 (36.8%) | 6/21 (28.6%) | 8/21 (38.1%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Anaemia | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 1/21 (4.8%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Leukopenia | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 1/40 (2.5%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Neutropenia | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 1/40 (2.5%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Eye disorders | ||||||||||||||||||
| Conjunctival erosion | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 1/21 (4.8%) | |||||||||
| Conjunctival haemorrhage | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Conjunctival hyperaemia | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Conjunctival oedema | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Conjunctivitis | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Dry eye | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Eye discharge | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 1/40 (2.5%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Eye irritation | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 3/21 (14.3%) | 3/19 (15.8%) | 2/21 (9.5%) | 2/21 (9.5%) | |||||||||
| Eye pain | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 1/39 (2.6%) | 0/21 (0%) | 1/19 (5.3%) | 1/21 (4.8%) | 1/21 (4.8%) | |||||||||
| Keratitis | 1/41 (2.4%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 2/21 (9.5%) | 0/21 (0%) | |||||||||
| Keratopathy | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Macular degeneration | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Meibomian gland dysfunction | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Ocular discomfort | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 1/19 (5.3%) | 1/21 (4.8%) | 1/21 (4.8%) | |||||||||
| Ocular hyperaemia | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 1/40 (2.5%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Photopsia | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Ulcerative keratitis | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 1/39 (2.6%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Vision blurred | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 1/21 (4.8%) | 2/19 (10.5%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Visual acuity reduced | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 1/21 (4.8%) | 1/19 (5.3%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal pain | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Abdominal pain upper | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Constipation | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 1/39 (2.6%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Diarrhoea | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Dry mouth | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 1/21 (4.8%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Dyspepsia | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Gastric polyps | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Gastritis | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Salivary gland pain | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Hepatobiliary disorders | ||||||||||||||||||
| Hepatic function abnormal | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Adenoviral conjunctivitis | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Dermatitis infected | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Gastroenteritis norovirus | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Gastroenteritis viral | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Herpes simplex | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Herpes zoster | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 1/21 (4.8%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Influenza | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Nasopharyngitis | 2/41 (4.9%) | 4/42 (9.5%) | 2/41 (4.9%) | 5/40 (12.5%) | 1/39 (2.6%) | 1/21 (4.8%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Upper respiratory tract infection | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Vaginal infection | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 1/21 (4.8%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Contusion | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Face injury | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Fall | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Joint sprain | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Periorbital haematoma | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Thermal burn | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Investigations | ||||||||||||||||||
| Alanine aminotransferase increased | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Aspartate aminotransferase increased | 0/41 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Blood bilirubin increased | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 1/40 (2.5%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Blood triglycerides increased | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| High density lipoprotein increased | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 1/40 (2.5%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Optic nerve cup/disc ratio increased | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 2/21 (9.5%) | |||||||||
| White blood cells urine positive | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 3/39 (7.7%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| Decreased appetite | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 1/39 (2.6%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Glucose tolerance impaired | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Arthralgia | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Back pain | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Tendonitis | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 1/39 (2.6%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||
| Lung neoplasm | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| Headache | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 1/39 (2.6%) | 0/21 (0%) | 1/19 (5.3%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Psychiatric disorders | ||||||||||||||||||
| Depression | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Insomnia | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Renal and urinary disorders | ||||||||||||||||||
| Haematuria | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Proteinuria | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 1/21 (4.8%) | 0/21 (0%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Cough | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 1/21 (4.8%) | |||||||||
| Oropharyngeal pain | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Dermatitis | 1/41 (2.4%) | 0/42 (0%) | 0/41 (0%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Eczema | 0/41 (0%) | 0/42 (0%) | 0/41 (0%) | 1/40 (2.5%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
| Vascular disorders | ||||||||||||||||||
| Orthostatic hypotension | 0/41 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/40 (0%) | 0/39 (0%) | 0/21 (0%) | 0/19 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01135511
Other Study ID Numbers:
- A3921072
First Posted:
Jun 2, 2010
Last Update Posted:
May 7, 2013
Last Verified:
Mar 1, 2013