A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00784719
• Collaborator: (none)
• Enrollment: 327
• Locations: 27
• Arms: 6
• Duration (Months): 11
• Patients Per Site: 12.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: CP-690,550; Drug: CP-690,550; Drug: CP-690,550; Drug: CP-690,550; Drug: Cyclosporine; Drug: CP-690,550 Vehicle	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 327 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Prospective, Randomized, Double Masked, Vehicle And Comparator Controlled, Dose Ranging Study Of CP-690,550 In Subjects With Dry Eye Disease.
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 1	Drug: CP-690,550; Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Experimental: Treatment 2	Drug: CP-690,550; Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Experimental: Treatment 3	Drug: CP-690,550; Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Experimental: Treatment 4	Drug: CP-690,550; Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Active Comparator: Active comparator	Drug: Cyclosporine; Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
Placebo Comparator: Placebo	Drug: CP-690,550 Vehicle; Ophthalmic topical solution, dosed at least once/day, 8 weeks

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Systemic Adverse Events (AEs) [Baseline up to Week 8]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.

2. Percentage of Participants With Ocular Adverse Events (AEs) [Baseline up to Week 8]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.

3. Percentage of Participants With Ocular Tolerability Assessment [Baseline up to Week 8]

   Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).

4. Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 [Week 8]

   Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Secondary Outcome Measures

1. Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia [Baseline through Week 8]

   Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

2. Time to Achieve 100 Percent (%) Clearance of Corneal Staining [Baseline through Week 8]

   Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

3. Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score [Baseline through Week 8]

   OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.

4. Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

   Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

5. Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 [Baseline, Week 8]

   Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

6. Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 [Week 1, 2, 4, 6]

   Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

7. Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 [Week 8]

   Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

8. Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

   Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

9. Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining [Week 1, 2, 4, 6, 8]

   Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

10. Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

    Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.

11. Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

    TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

12. Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

    OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.

13. Percentage of Participants With >= 5 Units Decrease in Total OCI Score [Week 1, 2, 4, 6, 8]

    OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.

14. Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

    Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.

15. Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

    OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.

16. Percentage of Participants With >= 10 Units Decrease in Total OSDI Score [Week 1, 2, 4, 6, 8]

    OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.

17. Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

    OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).

18. Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, 8]

    mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.

19. Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 [Baseline, Week 8]

    NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Symptoms of dry eye for at least 6 months.

• Signs of moderate to severe dry eye

Exclusion Criteria:

• Women who are nursing or pregnant

• 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	Chandler	Arizona	United States	85286
2	Pfizer Investigational Site	Peoria	Arizona	United States	85381
3	Pfizer Investigational Site	Phoenix	Arizona	United States	85032
4	Pfizer Investigational Site	Artesia	California	United States	90701
5	Pfizer Investigational Site	Centennial	Colorado	United States	80112
6	Pfizer Investigational Site	Ormond Beach	Florida	United States	32174
7	Pfizer Investigational Site	Stuart	Florida	United States	34994
8	Pfizer Investigational Site	Tamarac	Florida	United States	33321
9	Pfizer Investigational Site	Tampa	Florida	United States	33603
10	Pfizer Investigational Site	Atlanta	Georgia	United States	30342
11	Pfizer Investigational Site	Morrow	Georgia	United States	30260
12	Pfizer Investigational Site	Roswell	Georgia	United States	30076
13	Pfizer Investigational Site	Louisville	Kentucky	United States	40217
14	Pfizer Investigational Site	Baltimore	Maryland	United States	21287
15	Pfizer Investigational Site	Boston	Massachusetts	United States	02114
16	Pfizer Investigational Site	Kansas City	Missouri	United States	64111
17	Pfizer Investigational Site	Lynbrook	New York	United States	11563
18	Pfizer Investigational Site	Rochester	New York	United States	14618
19	Pfizer Investigational Site	Charlotte	North Carolina	United States	28210
20	Pfizer Investigational Site	High Point	North Carolina	United States	27262
21	Pfizer Investigational Site	Cleveland	Ohio	United States	44115
22	Pfizer Investigational Site	Columbus	Ohio	United States	43210
23	Pfizer Investigational Site	Memphis	Tennessee	United States	38119
24	Pfizer Investigational Site	Austin	Texas	United States	78705
25	Pfizer Investigational Site	Austin	Texas	United States	78731
26	Pfizer Investigational Site	Austin	Texas	United States	78746
27	Pfizer Investigational Site	San Antonio	Texas	United States	78240

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00784719
• Other Study ID Numbers: A3921034; A3921034
• First Posted: Nov 4, 2008
• Last Update Posted: Apr 9, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Pfizer: Dry eye
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Cyclosporine; Cyclosporins; Tofacitinib

Study Results

Participant Flow

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Period Title: Overall Study
STARTED	47	46	47	48	48	44	47
COMPLETED	44	43	46	48	42	41	42
NOT COMPLETED	3	3	1	0	6	3	5

Baseline Characteristics

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily	Total
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.	Total of all reporting groups
Overall Participants	47	46	47	48	48	44	47	327
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (12.54)	59.5 (11.57)	60.7 (11.73)	58.7 (14.57)	59.9 (11.69)	59.8 (14.83)	58.9 (14.25)	60.0 (13.02)
Sex: Female, Male (Count of Participants)
Female	32 68.1%	35 76.1%	40 85.1%	34 70.8%	39 81.3%	37 84.1%	38 80.9%	255 78%
Male	15 31.9%	11 23.9%	7 14.9%	14 29.2%	9 18.8%	7 15.9%	9 19.1%	72 22%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Systemic Adverse Events (AEs)
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Time Frame	Baseline up to Week 8

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Number [percentage of participants]	27.7 58.9%	8.7 18.9%	29.8 63.4%	27.1 56.5%	18.8 39.2%	18.2 41.4%	23.4 49.8%

2. Primary Outcome

Title	Percentage of Participants With Ocular Adverse Events (AEs)
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
Time Frame	Baseline up to Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Number [percentage of participants]	25.5 54.3%	21.7 47.2%	31.9 67.9%	22.9 47.7%	22.9 47.7%	22.7 51.6%	36.2 77%

3. Primary Outcome

Title	Percentage of Participants With Ocular Tolerability Assessment
Description	Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).
Time Frame	Baseline up to Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	45	46	47	48	47	43	44
Ocular discomfort:none	55.6 118.3%	50.0 108.7%	53.2 113.2%	52.1 108.5%	46.8 97.5%	69.8 158.6%	34.1 72.6%
Ocular discomfort:mild	33.3 70.9%	28.3 61.5%	25.5 54.3%	29.2 60.8%	44.7 93.1%	18.6 42.3%	34.1 72.6%
Ocular discomfort:moderate	11.1 23.6%	19.6 42.6%	19.1 40.6%	14.6 30.4%	8.5 17.7%	9.3 21.1%	25.0 53.2%
Ocular discomfort:severe	0.0 0%	2.2 4.8%	2.1 4.5%	4.2 8.8%	0.0 0%	2.3 5.2%	6.8 14.5%
Ocular discomfort:moderate/severe, duration>=5 min	4.4 9.4%	10.9 23.7%	8.5 18.1%	10.4 21.7%	4.3 9%	7.0 15.9%	22.7 48.3%
Burning sensation:none	26.7 56.8%	43.5 94.6%	23.4 49.8%	33.3 69.4%	29.8 62.1%	32.6 74.1%	18.2 38.7%
Burning sensation:mild	55.6 118.3%	39.1 85%	59.6 126.8%	39.6 82.5%	53.2 110.8%	48.8 110.9%	40.9 87%
Burning sensation:moderate	17.8 37.9%	15.2 33%	14.9 31.7%	22.9 47.7%	14.9 31%	16.3 37%	36.4 77.4%
Burning sensation:severe	0.0 0%	2.2 4.8%	2.1 4.5%	4.2 8.8%	2.1 4.4%	2.3 5.2%	4.5 9.6%
Burning sensation:moderate/severe,duration>=5 min	0.0 0%	2.2 4.8%	2.1 4.5%	0.0 0%	4.3 9%	4.7 10.7%	11.4 24.3%
Pain:none	82.2 174.9%	80.4 174.8%	80.9 172.1%	85.4 177.9%	85.1 177.3%	88.4 200.9%	61.4 130.6%
Pain:mild	13.3 28.3%	10.9 23.7%	8.5 18.1%	6.3 13.1%	12.8 26.7%	7.0 15.9%	25.0 53.2%
Pain:moderate	4.4 9.4%	6.5 14.1%	6.4 13.6%	6.3 13.1%	2.1 4.4%	2.3 5.2%	9.1 19.4%
Pain:severe	0.0 0%	2.2 4.8%	4.3 9.1%	2.1 4.4%	0.0 0%	2.3 5.2%	4.5 9.6%
Pain:moderate/severe, duration >=5 min	2.2 4.7%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Tearing:none	55.6 118.3%	63.0 137%	68.1 144.9%	72.9 151.9%	66.0 137.5%	69.8 158.6%	47.7 101.5%
Tearing:mild	40.0 85.1%	26.1 56.7%	21.3 45.3%	16.7 34.8%	29.8 62.1%	11.6 26.4%	29.5 62.8%
Tearing:moderate	4.4 9.4%	10.9 23.7%	10.6 22.6%	10.4 21.7%	4.3 9%	18.6 42.3%	11.4 24.3%
Tearing:severe	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	11.4 24.3%
Tearing:moderate/severe, duration >= 5 min	0.0 0%	2.2 4.8%	6.4 13.6%	2.1 4.4%	0.0 0%	4.7 10.7%	6.8 14.5%
Blurred vision:none	51.1 108.7%	54.3 118%	53.2 113.2%	58.3 121.5%	51.1 106.5%	44.2 100.5%	36.4 77.4%
Blurred vision:mild	40.0 85.1%	30.4 66.1%	34.0 72.3%	27.1 56.5%	36.2 75.4%	34.9 79.3%	40.9 87%
Blurred vision:moderate	6.7 14.3%	15.2 33%	12.8 27.2%	8.3 17.3%	8.5 17.7%	18.6 42.3%	20.5 43.6%
Blurred vision:severe	2.0 4.3%	0.0 0%	0.0 0%	6.3 13.1%	4.3 9%	2.3 5.2%	2.3 4.9%
Blurred vision:moderate/severe, duration >=5 min	0.0 0%	2.2 4.8%	4.3 9.1%	4.2 8.8%	6.4 13.3%	7.0 15.9%	2.3 4.9%

4. Primary Outcome

Title	Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
Description	Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	45	45	47	48	46	44	45
Number [percentage of participants]	20.0 42.6%	17.8 38.7%	25.5 54.3%	18.8 39.2%	26.1 54.4%	27.3 62%	35.6 75.7%

5. Secondary Outcome

Title	Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
Description	Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Baseline through Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Median (95% Confidence Interval) [days]	NA	NA	59.00	58.00	NA	57.00	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550, 0.001% Twice Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	59.00
	Confidence Interval	(2-Sided) 80%; 57.0 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550, 0.003% Twice Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	58.00
	Confidence Interval	(2-Sided) 80%; 58.0 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CP-690,550, 0.005% Once Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	57.00
	Confidence Interval	(2-Sided) 80%; 29.0 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Time to Achieve 100 Percent (%) Clearance of Corneal Staining
Description	Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Baseline through Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Median (95% Confidence Interval) [days]	NA	NA	NA	NA	NA	NA	NA

7. Secondary Outcome

Title	Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
Description	OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Time Frame	Baseline through Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Median (95% Confidence Interval) [days]	15.00	8.50	15.00	9.50	9.00	15.00	16.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo Twice Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	15.00
	Confidence Interval	(2-Sided) 80%; 9.0 to 28.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550, 0.0003% Twice Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	8.50
	Confidence Interval	(2-Sided) 80%; 8.0 to 27.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CP-690,550, 0.001% Twice Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	15.00
	Confidence Interval	(2-Sided) 80%; 15.0 to 27.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CP-690,550, 0.003% Twice Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	9.50
	Confidence Interval	(2-Sided) 80%; 8.0 to 15.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	CP-690,550, 0.005% Twice Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	9.00
	Confidence Interval	(2-Sided) 80%; 8.0 to 15.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	CP-690,550, 0.005% Once Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	15.00
	Confidence Interval	(2-Sided) 80%; 8.0 to 43.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Restasis Twice Daily
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median
	Estimated Value	16.00
	Confidence Interval	(2-Sided) 80%; 15.0 to 30.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Description	Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Baseline (n=47,46,47,48,48,44,47)	4.15 (2.07)	4.40 (2.20)	4.02 (2.12)	3.77 (1.87)	4.43 (2.29)	4.40 (2.24)	4.74 (2.03)
Change at Week 1 (n=45,45,47,47,44,42,43)	2.06 (4.54)	1.68 (4.69)	0.80 (3.03)	2.07 (3.87)	1.80 (4.64)	2.68 (6.11)	3.60 (5.44)
Change at Week 2 (n=44,46,46,48,45,44,44)	2.43 (4.98)	1.63 (4.04)	2.67 (4.44)	3.13 (4.61)	2.74 (4.60)	3.43 (6.62)	3.84 (5.66)
Change at Week 4 (n=44,43,45,48,44,39,43)	2.42 (6.64)	2.69 (4.56)	2.56 (4.76)	1.72 (3.60)	1.66 (5.03)	4.21 (7.03)	4.06 (6.65)
Change at Week 6 (n=43,44,43,47,42,41,43)	1.86 (3.82)	1.41 (3.27)	1.59 (3.55)	1.76 (4.11)	3.64 (6.57)	4.65 (6.30)	3.87 (5.75)
Change at Week 8 (n=45,46,47,48,47,44,45)	1.89 (5.22)	2.30 (4.73)	2.19 (4.22)	3.59 (6.22)	2.60 (4.80)	3.76 (6.28)	4.48 (7.05)

9. Secondary Outcome

Title	Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Description	Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	43	47
Baseline (n=47,46,47,48,48,43,47)	6.56 (4.69)	7.58 (4.44)	6.63 (5.05)	6.67 (4.01)	7.85 (5.35)	7.92 (5.13)	8.14 (5.75)
Change at Week 8 (n=43,43,45,48,41,39,42)	2.24 (5.07)	0.13 (5.47)	2.56 (6.11)	1.48 (5.48)	-0.44 (5.13)	0.83 (6.04)	1.74 (5.74)

10. Secondary Outcome

Title	Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Description	Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Week 1, 2, 4, 6

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	45	45	47	48	44	44	44
Week 1	20.0 42.6%	9.1 19.8%	6.4 13.6%	14.9 31%	11.6 24.2%	16.7 38%	30.2 64.3%
Week 2	18.2 38.7%	20.0 43.5%	23.9 50.9%	16.7 34.8%	25.0 52.1%	22.7 51.6%	36.4 77.4%
Week 4	18.2 38.7%	20.9 45.4%	17.8 37.9%	10.4 21.7%	16.3 34%	28.2 64.1%	30.2 64.3%
Week 6	20.9 44.5%	9.1 19.8%	16.3 34.7%	12.8 26.7%	34.1 71%	39.0 88.6%	34.9 74.3%

11. Secondary Outcome

Title	Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
Description	Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	43	43	45	48	41	39	42
Number [percentage of participants]	32.6 69.4%	27.9 60.7%	48.9 104%	31.3 65.2%	24.4 50.8%	25.6 58.2%	38.1 81.1%

12. Secondary Outcome

Title	Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Description	Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Baseline (n=47,46,47,48,48,44,47)	6.64 (3.45)	5.63 (1.95)	5.83 (2.10)	6.73 (2.94)	6.21 (2.54)	6.36 (2.71)	6.85 (3.50)
Change at Week 1 (n=45,45,47,47,44,42,44)	-1.16 (2.39)	-0.89 (2.05)	-0.87 (2.25)	-1.32 (2.58)	-0.20 (1.95)	-1.17 (2.51)	0.02 (3.27)
Change at Week 2 (n=44,46,46,48,45,44,44)	-1.02 (3.16)	-1.15 (2.33)	-1.00 (2.19)	-1.98 (2.50)	-0.91 (2.26)	-1.52 (2.73)	-0.61 (2.94)
Change at Week 4 (n=44,43,45,48,44,39,43)	-2.48 (2.53)	-1.02 (2.58)	-1.33 (2.69)	-1.40 (2.54)	-0.82 (2.45)	-2.10 (2.31)	-1.00 (2.86)
Change at Week 6 (n=43,44,43,48,42,41,43)	-2.21 (3.49)	-1.39 (2.50)	-1.21 (2.42)	-1.75 (3.06)	-1.31 (3.00)	-2.27 (2.69)	-1.49 (3.03)
Change at Week 8 (n=45,46,47,48,47,44,45)	-2.67 (3.44)	-1.39 (2.92)	-1.28 (2.65)	-1.58 (3.04)	-1.47 (2.73)	-2.64 (2.94)	-1.18 (3.50)

13. Secondary Outcome

Title	Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Description	Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	45	46	47	48	48	44	44
Week 1	2.2 4.7%	0.0 0%	0.0 0%	0.0 0%	0.0 0%	4.8 10.9%	0.0 0%
Week 2	2.3 4.9%	4.3 9.3%	0.0 0%	4.2 8.8%	0.0 0%	4.5 10.2%	0.0 0%
Week 4	4.5 9.6%	2.3 5%	4.4 9.4%	6.3 13.1%	2.3 4.8%	2.6 5.9%	4.7 10%
Week 6	4.7 10%	6.8 14.8%	7.0 14.9%	4.2 8.8%	7.1 14.8%	7.3 16.6%	7.0 14.9%
Week 8	6.7 14.3%	6.5 14.1%	4.3 9.1%	10.4 21.7%	6.4 13.3%	15.9 36.1%	4.5 9.6%

14. Secondary Outcome

Title	Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Description	Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	43	47
Baseline (n=47,46,47,48,48,43,47)	2.77 (2.36)	2.17 (1.43)	2.21 (1.81)	2.38 (2.08)	2.17 (1.99)	1.91 (1.66)	2.43 (2.03)
Change at Week 1 (n=45,45,47,47,44,42,43)	-0.44 (1.52)	-0.38 (1.76)	-0.34 (1.75)	-0.13 (2.06)	-0.45 (1.42)	0.17 (1.50)	-0.09 (1.92)
Change at Week 2 (n=44,46,46,48,45,43,44)	-0.89 (1.53)	-0.26 (1.41)	-0.37 (1.44)	-0.29 (1.57)	-0.44 (1.62)	-0.19 (1.38)	0.05 (2.47)
Change at Week 4 (n=44,43,45,48,44,39,43)	-1.11 (1.86)	-0.53 (1.65)	-0.60 (1.56)	-0.27 (1.87)	-0.11 (1.37)	0.18 (1.35)	-0.07 (1.64)
Change at Week 6 (n=43,44,43,48,42,41,43)	-0.84 (1.38)	-0.73 (1.63)	-0.44 (1.74)	-0.46 (1.68)	-0.12 (1.71)	0.02 (1.98)	-0.14 (1.90)
Change at Week 8 (n=45,46,47,48,47,43,45)	-0.82 (2.01)	-0.57 (1.78)	-0.62 (1.81)	-0.63 (1.71)	-0.13 (1.78)	-0.14 (1.82)	-0.18 (1.57)

15. Secondary Outcome

Title	Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Description	TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Baseline (n=47,46,47,48,48,43,47)	3.50 (1.32)	3.96 (3.30)	4.32 (2.74)	4.65 (6.50)	4.12 (2.44)	3.90 (2.47)	3.95 (2.30)
Change at Week 1 (n=45,45,47,47,44,42,44)	0.17 (1.63)	0.60 (2.11)	0.21 (2.50)	-0.27 (1.55)	-0.07 (1.26)	-0.51 (2.24)	-0.14 (2.00)
Change at Week 2 (n=44,46,46,48,45,43,44)	0.03 (1.40)	1.04 (4.49)	0.24 (3.08)	-0.44 (3.80)	-0.18 (1.01)	0.04 (2.59)	0.36 (2.96)
Change at Week 4 (n=44,43,45,48,44,39,43)	0.48 (2.14)	0.61 (2.95)	-0.11 (2.31)	-0.30 (4.21)	0.10 (1.50)	-0.08 (2.37)	0.52 (2.43)
Change at Week 6 (n=43,44,43,48,42,41,43)	1.03 (4.65)	0.36 (2.77)	-0.01 (2.46)	-0.71 (4.85)	0.13 (1.45)	-0.21 (2.51)	0.59 (3.32)
Change at Week 8 (n=45,46,47,48,47,43,45)	0.55 (2.19)	0.51 (2.93)	-0.18 (2.30)	-0.04 (5.01)	0.08 (1.50)	0.31 (3.54)	0.52 (3.07)

16. Secondary Outcome

Title	Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Description	OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	44	47
Baseline (n=47,46,47,48,48,44,47)	45.0 (7.66)	43.9 (8.09)	44.8 (7.69)	46.0 (11.22)	45.4 (8.41)	42.3 (7.01)	47.4 (12.51)
Change at Week 1 (n=45,45,47,47,44,41,43)	-3.7 (7.28)	-5.9 (6.44)	-4.2 (6.49)	-3.9 (7.68)	-7.7 (9.99)	-4.3 (7.70)	-3.8 (7.79)
Change at Week 2 (n=44,46,46,48,45,43,44)	-6.3 (7.89)	-6.0 (5.92)	-6.2 (9.00)	-5.9 (7.30)	-7.6 (9.89)	-4.4 (9.13)	-6.8 (10.59)
Change at Week 4 (n=44,43,45,48,44,41,43)	-8.9 (8.44)	-7.6 (9.73)	-6.8 (8.58)	-5.7 (11.33)	-8.5 (10.88)	-6.1 (8.33)	-5.2 (8.23)
Change at Week 6 (n=43,44,43,48,42,41,43)	-10.1 (9.75)	-9.1 (9.35)	-8.8 (7.46)	-7.5 (10.31)	-8.0 (9.72)	-7.3 (10.88)	-7.2 (9.36)
Change at Week 8 (n=45,46,47,48,47,44,44)	-9.6 (8.98)	-9.9 (9.47)	-8.0 (8.81)	-7.4 (11.34)	-8.4 (9.42)	-8.8 (9.51)	-7.1 (10.16)

17. Secondary Outcome

Title	Percentage of Participants With >= 5 Units Decrease in Total OCI Score
Description	OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.
Time Frame	Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	45	46	47	48	47	44	44
Week 1	44.4 94.5%	53.3 115.9%	38.3 81.5%	53.2 110.8%	56.8 118.3%	43.9 99.8%	39.5 84%
Week 2	56.8 120.9%	52.2 113.5%	45.7 97.2%	62.5 130.2%	57.8 120.4%	48.8 110.9%	52.3 111.3%
Week 4	68.2 145.1%	60.5 131.5%	55.6 118.3%	58.3 121.5%	65.9 137.3%	51.2 116.4%	46.5 98.9%
Week 6	72.1 153.4%	68.2 148.3%	72.1 153.4%	62.5 130.2%	61.9 129%	51.2 116.4%	51.2 108.9%
Week 8	64.4 137%	71.7 155.9%	59.6 126.8%	60.4 125.8%	57.4 119.6%	59.1 134.3%	52.3 111.3%

18. Secondary Outcome

Title	Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Description	Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	43	47
Baseline (n=47,46,47,48,48,43,47)	3.4 (1.58)	3.0 (1.63)	3.0 (1.16)	2.5 (1.65)	3.0 (1.65)	2.8 (1.20)	2.9 (1.60)
Change at Week 1 (n=45,46,47,48,47,43,45)	-0.7 (1.27)	-1.1 (0.99)	-0.8 (1.01)	-0.8 (1.01)	-0.9 (1.33)	-1.1 (1.01)	-0.6 (1.17)
Change at Week 2 (n=44,46,45,48,47,42,44)	-0.9 (1.31)	-1.2 (1.09)	-0.8 (1.20)	-0.9 (0.99)	-0.9 (1.28)	-1.0 (1.03)	-0.6 (1.21)
Change at Week 4 (n=44,44,45,48,45,41,44)	-1.1 (1.60)	-1.5 (1.22)	-0.9 (1.08)	-1.0 (0.95)	-0.9 (1.29)	-1.2 (1.27)	-0.8 (1.42)
Change at Week 6 (n=44,44,46,48,43,40,43)	-1.5 (1.51)	-1.5 (1.08)	-0.9 (1.15)	-1.1 (1.07)	-1.0 (1.60)	-1.3 (1.10)	-0.7 (1.33)
Change at Week 8 (n=46,46,47,48,47,43,46)	-1.2 (1.36)	-1.6 (1.20)	-1.0 (1.19)	-1.2 (1.04)	-1.1 (1.52)	-1.5 (1.27)	-0.9 (1.34)

19. Secondary Outcome

Title	Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Description	OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population. LOCF method was used for imputing missing data at Week 8. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	46	48	48	43	47
Baseline:total (n=47,46,46,48,48,43,47)	37.6 (21.46)	35.6 (19.71)	31.5 (17.95)	41.8 (22.04)	37.8 (18.76)	35.6 (22.45)	41.8 (22.93)
Baseline:symptoms (n=47,46,46,48,48,43,47)	39.7 (22.87)	38.8 (21.60)	38.6 (20.66)	45.7 (24.37)	41.7 (22.87)	35.9 (20.86)	47.3 (24.64)
Baseline:function (n=46,46,45,48,47,43,44)	31.8 (21.05)	28.8 (20.30)	23.5 (19.55)	38.3 (26.66)	31.8 (20.74)	31.3 (27.07)	36.1 (26.02)
Baseline:triggers (n=46,41,42,45,42,41,43)	46.7 (30.81)	49.8 (29.64)	42.0 (31.63)	46.1 (29.64)	45.6 (29.52)	44.8 (26.92)	50.3 (30.12)
Change at Week 1:total (n=45,45,46,47,44,40,43)	-6.8 (14.39)	-5.1 (13.61)	-6.3 (13.79)	-8.9 (11.43)	-6.5 (17.18)	-9.2 (17.13)	-4.7 (12.46)
Change at Week 1:symptoms (n=45,45,46,47,44,40,43)	-5.9 (16.73)	-4.1 (15.85)	-8.5 (17.52)	-8.2 (17.59)	-6.3 (20.26)	-6.9 (17.99)	-4.5 (13.03)
Change at Week 1:function (n=43,45,44,47,43,39,39)	-6.1 (15.49)	-3.7 (16.32)	-4.4 (13.48)	-9.1 (14.77)	-4.4 (19.94)	-9.1 (17.81)	-7.3 (16.84)
Change at Week 1:triggers (n=43,39,39,43,38,35,39)	-7.9 (23.64)	-12.0 (24.05)	-6.6 (24.74)	-10.2 (18.88)	-14.7 (23.12)	-15.0 (28.19)	-2.4 (18.97)
Change at Week 2:total (n=44,46,45,48,45,43,44)	-8.7 (12.60)	-6.2 (12.09)	-8.6 (13.66)	-8.9 (13.08)	-4.7 (19.01)	-10.3 (20.16)	-7.3 (16.51)
Change at Week 2:symptoms (n=44,46,45,48,45,43,44)	-9.1 (18.49)	-6.2 (13.99)	-11.5 (17.79)	-11.5 (18.12)	-6.9 (19.41)	-9.7 (21.74)	-7.6 (17.77)
Change at Week 2:function (n=42,46,42,48,43,43,41)	-8.6 (14.26)	-5.8 (13.67)	-5.5 (12.92)	-7.6 (16.52)	-3.5 (23.92)	-7.0 (19.10)	-8.6 (19.44)
Change at Week 2:triggers (n=42,40,40,38,35,39,40)	-9.9 (18.38)	-7.9 (24.98)	-8.8 (24.76)	-9.4 (16.60)	-10.1 (29.00)	-19.2 (29.05)	-5.5 (21.42)
Change at Week 4:total (n=44,43,44,48,44,41,43)	-11.5 (15.88)	-7.2 (12.98)	-8.1 (15.53)	-9.7 (14.12)	-10.0 (20.92)	-11.3 (17.12)	-7.0 (13.95)
Change at Week 4:symptoms (n=44,43,44,48,44,41,43)	-12.1 (18.19)	-8.5 (12.79)	-13.4 (20.27)	-10.9 (18.37)	-10.8 (23.47)	-10.4 (18.61)	-6.6 (15.06)
Change at Week 4:function (n=43,42,42,47,41,41,40)	-10.2 (16.42)	-4.7 (15.98)	-6.3 (16.97)	-8.5 (16.77)	-5.1 (20.37)	-7.3 (18.75)	-8.7 (17.83)
Change at Week 4:triggers (n=43,36,39,43,36,37,39)	-13.5 (26.02)	-10.4 (21.90)	-5.8 (30.16)	-9.8 (23.23)	-16.3 (29.55)	-21.5 (25.07)	-4.7 (20.90)
Change at Week 6:total (n=43,44,42,48,42,41,43)	-10.5 (14.26)	-9.1 (14.19)	-7.9 (13.89)	-10.9 (14.33)	-8.1 (20.48)	-14.0 (19.43)	-7.7 (14.00)
Change at Week 6:symptoms (n=43,44,42,48,42,41,43)	-11.2 (18.36)	-10.0 (13.76)	-12.3 (17.96)	-11.4 (19.52)	-7.1 (21.03)	-13.4 (21.80)	-9.1 (15.52)
Change at Week 6:function (n=42,44,38,46,40,41,40)	-9.1 (18.88)	-7.0 (15.30)	-5.1 (14.46)	-9.6 (14.74)	-3.7 (20.10)	-9.3 (19.34)	-8.3 (17.09)
Change at Week 6:triggers (n=40,38,37,41,34,38,39)	-13.2 (21.62)	-13.0 (24.80)	-9.7 (23.61)	-9.2 (24.85)	-12.4 (32.88)	-24.5 (28.3)	-5.9 (22.65)
Change at Week 8:total (n=45,46,46,48,32,35,39)	-11.0 (18.55)	-8.5 (15.34)	-7.6 (15.22)	-8.8 (16.56)	-9.5 (20.92)	-12.7 (18.21)	-6.6 (16.11)
Change at Week 8:symptoms (n=45,46,46,48,47,43,44)	-13.1 (20.37)	-8.9 (16.14)	-11.6 (20.52)	-11.6 (20.68)	-10.5 (23.98)	-14.3 (21.54)	-7.4 (17.72)
Change at Week 8:function (n=44,46,45,48,46,43,41)	-9.1 (21.31)	-6.4 (16.54)	-4.5 (14.82)	-9.2 (18.33)	-6.2 (23.86)	-9.2 (18.31)	-6.8 (19.72)
Change at Week 8:triggers(n=44,41,42,45,,41,41,41)	-12.2 (24.86)	-14.2 (24.46)	-8.4 (23.62)	-6.4 (29.08)	-13.5 (29.07)	-19.6 (26.06)	-4.8 (23.62)

20. Secondary Outcome

Title	Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
Description	OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.
Time Frame	Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	45	46	46	48	47	43	44
Week 1	37.8 80.4%	37.8 82.2%	34.8 74%	46.8 97.5%	45.5 94.8%	40.0 90.9%	37.2 79.1%
Week 2	50.0 106.4%	45.7 99.3%	40.0 85.1%	43.8 91.3%	33.3 69.4%	39.5 89.8%	43.2 91.9%
Week 4	47.7 101.5%	44.2 96.1%	38.6 82.1%	50.0 104.2%	45.5 94.8%	41.5 94.3%	44.2 94%
Week 6	46.5 98.9%	52.3 113.7%	35.7 76%	52.1 108.5%	40.5 84.4%	51.2 116.4%	39.5 84%
Week 8	40.0 85.1%	50.0 108.7%	41.3 87.9%	47.9 99.8%	44.7 93.1%	46.5 105.7%	38.6 82.1%

21. Secondary Outcome

Title	Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8
Description	OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	0	0	0	0	0	0	0

22. Secondary Outcome

Title	Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8
Description	mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.
Time Frame	Baseline, Week 1, 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	0	0	0	0	0	0	0

23. Secondary Outcome

Title	Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Description	NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.

Arm/Group Title	Placebo Twice Daily	CP-690,550, 0.0003% Twice Daily	CP-690,550, 0.001% Twice Daily	CP-690,550, 0.003% Twice Daily	CP-690,550, 0.005% Twice Daily	CP-690,550, 0.005% Once Daily	Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.	One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.	One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Measure Participants	47	46	47	48	48	43	47
Baseline: GH (n=46,46,47,48,48,43,47)	65.22 (20.74)	66.85 (21.12)	62.77 (20.10)	66.15 (24.99)	59.90 (23.49)	66.86 (25.43)	57.98 (20.92)
Baseline: GV (n=47,46,47,48,48,43,47)	72.77 (16.38)	75.65 (12.59)	73.62 (14.51)	72.50 (20.05)	72.08 (13.52)	70.70 (17.10)	73.19 (13.37)
Baseline: OP (n=47,46,47,48,48,43,47)	59.31 (18.70)	59.51 (18.85)	61.17 (20.89)	53.65 (23.06)	55.47 (19.28)	56.40 (17.76)	50.27 (24.76)
Baseline: NAct (n=47,46,47,48,48,43,47)	68.62 (18.49)	70.92 (17.53)	76.60 (18.60)	64.41 (23.36)	66.06 (20.01)	72.00 (21.53)	64.36 (23.36)
Baseline: DA (n=47,46,47,48,48,43,47)	73.76 (17.63)	77.36 (17.71)	81.38 (16.32)	72.05 (25.12)	73.00 (17.13)	71.90 (20.66)	69.33 (21.92)
Baseline: SF (n=47,46,47,48,48,43,47)	89.10 (14.89)	93.21 (10.77)	93.88 (11.62)	86.46 (21.39)	89.84 (14.51)	87.79 (18.99)	85.64 (20.52)
Baseline: MH (n=47,46,47,48,48,43,47)	72.34 (24.55)	73.23 (19.88)	77.53 (19.71)	64.84 (26.13)	67.97 (22.94)	72.67 (22.24)	70.35 (23.73)
Baseline: RD (n=47,46,47,48,48,43,47)	68.09 (23.28)	72.83 (20.12)	76.33 (25.96)	61.98 (29.73)	67.71 (26.02)	68.02 (26.91)	68.09 (27.81)
Baseline:dependency (n=47,45,47,47,48,43,47)	88.48 (21.46)	93.89 (10.42)	94.33 (11.54)	81.91 (25.79)	88.02 (23.34)	87.79 (22.15)	89.72 (19.90)
Baseline:driving (n=46,44,45,46,41,41,44)	73.64 (17.15)	76.89 (15.65)	77.22 (19.09)	78.44 (20.38)	71.54 (22.28)	71.65 (21.23)	71.12 (19.80)
Baseline: CV (n=46,46,47,48,48,43,47)	89.67 (21.46)	96.20 (9.08)	93.62 (13.26)	90.10 (18.41)	93.75 (14.12)	91.28 (17.15)	90.43 (17.72)
Baseline: PV (n=47,46,46,48,46,43,47)	77.13 (23.21)	82.61 (20.32)	85.87 (21.51)	80.21 (25.24)	79.89 (21.49)	79.65 (26.31)	80.32 (22.68)
Baseline: Overall (n=47,46,47,48,48,43,47)	75.62 (14.43)	79.30 (10.95)	81.08 (12.99)	73.19 (19.31)	75.06 (13.96)	75.40 (15.58)	73.97 (16.76)
Change at Week 8: GH (n=42,43,44,48,41,40,41)	0.00 (13.53)	-2.91 (14.65)	0.00 (15.25)	2.08 (19.18)	1.22 (18.50)	-0.63 (14.42)	1.83 (10.29)
Change at Week 8: GV (n=43,43,44,48,41,40,41)	1.86 (16.22)	1.86 (12.20)	1.36 (7.95)	3.75 (12.82)	1.46 (18.11)	5.00 (15.53)	-0.49 (10.48)
Change at Week 8: OP (n=43,43,44,48,41,40,41)	15.12 (19.59)	11.63 (21.89)	13.35 (20.95)	9.38 (15.79)	11.59 (19.24)	16.56 (20.88)	9.45 (19.72)
Change at Week 8: NAct (n=43,43,44,48,41,40,41)	7.17 (17.21)	8.62 (15.33)	4.17 (12.64)	7.12 (16.49)	10.87 (19.07)	7.40 (15.49)	9.96 (19.65)
Change at Week 8: DA (n=43,43,44,48,41,40,41)	6.78 (12.50)	5.43 (13.22)	3.03 (13.46)	4.43 (11.32)	8.84 (17.88)	8.85 (17.66)	5.89 (14.67)
Change at Week 8: SF (n=43,43,44,48,41,40,41)	3.20 (12.82)	2.62 (11.75)	2.27 (10.54)	3.39 (13.58)	5.79 (13.43)	6.88 (18.55)	8.23 (12.06)
Change at Week 8: MH (n=43,43,44,48,41,40,41)	10.61 (19.27)	9.59 (17.27)	4.55 (13.57)	5.34 (15.95)	11.28 (18.92)	10.63 (22.30)	5.95 (16.41)
Change at Week 8: RD (n=43,43,44,48,41,40,41)	6.98 (15.74)	5.52 (27.59)	4.55 (20.37)	5.47 (18.93)	8.23 (24.94)	12.50 (25.94)	0.00 (29.05)
Change Week 8:dependency(n=43,42,44,47,41,40,41)	7.56 (21.32)	1.19 (15.79)	1.89 (8.96)	4.61 (14.83)	5.39 (19.59)	7.08 (17.45)	2.24 (11.94)
Change at Week 8:driving (n=42,41,42,46,33,38,39)	6.15 (14.47)	3.46 (16.24)	3.27 (13.64)	0.36 (12.29)	3.91 (14.43)	8.22 (13.65)	3.95 (13.07)
Change at Week 8: CV (n=42,43,44,48,41,40,41)	4.76 (13.79)	2.33 (9.15)	3.98 (10.71)	2.08 (16.97)	2.44 (13.47)	5.63 (19.19)	4.88 (16.03)
Change at Week 8: PV (n=43,43,44,48,39,40,41)	11.05 (22.03)	4.07 (15.36)	1.70 (15.62)	3.65 (18.59)	6.41 (21.24)	6.88 (20.40)	6.71 (20.17)
Change at Week 8: Overall (n=43,43,44,48,41,40,41)	7.44 (9.55)	5.13 (9.20)	3.98 (7.44)	4.50 (8.19)	7.15 (11.60)	8.67 (11.50)	5.15 (10.42)

Adverse Events

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	Placebo Twice Daily		CP-690,550, 0.0003% Twice Daily		CP-690,550, 0.001% Twice Daily		CP-690,550, 0.003% Twice Daily		CP-690,550, 0.005% Twice Daily		CP-690,550, 0.005% Once Daily		Restasis Twice Daily
Arm/Group Description	One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.		One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.		One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.		One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.		One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.		One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.		One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
All Cause Mortality
	Placebo Twice Daily		CP-690,550, 0.0003% Twice Daily		CP-690,550, 0.001% Twice Daily		CP-690,550, 0.003% Twice Daily		CP-690,550, 0.005% Twice Daily		CP-690,550, 0.005% Once Daily		Restasis Twice Daily
	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)
Serious Adverse Events
	Placebo Twice Daily		CP-690,550, 0.0003% Twice Daily		CP-690,550, 0.001% Twice Daily		CP-690,550, 0.003% Twice Daily		CP-690,550, 0.005% Twice Daily		CP-690,550, 0.005% Once Daily		Restasis Twice Daily
	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	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		1/48 (2.1%)		1/48 (2.1%)		1/44 (2.3%)		1/47 (2.1%)
Infections and infestations
Diverticulitis	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Pneumonia	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Injury, poisoning and procedural complications
Drug exposure during pregnancy	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Fall	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Hip fracture	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Lower limb fracture	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Nervous system disorders
Syncope	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Vascular disorders
Thrombosis	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Twice Daily		CP-690,550, 0.0003% Twice Daily		CP-690,550, 0.001% Twice Daily		CP-690,550, 0.003% Twice Daily		CP-690,550, 0.005% Twice Daily		CP-690,550, 0.005% Once Daily		Restasis Twice Daily
	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	23/47 (48.9%)		11/46 (23.9%)		22/47 (46.8%)		21/48 (43.8%)		15/48 (31.3%)		15/44 (34.1%)		26/47 (55.3%)
Cardiac disorders
Bradycardia	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Ear and labyrinth disorders
Ear disorder	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Eye disorders
Abnormal sensation in eye, BOTH EYES	1/47 (2.1%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Asthenopia, BOTH EYES	0/47 (0%)		1/46 (2.2%)		1/47 (2.1%)		1/48 (2.1%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Blepharitis, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Cataract nuclear, BOTH EYES	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Chalazion, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Conjunctival cyst, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Conjunctival hyperaemia, BOTH EYES	1/47 (2.1%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		1/48 (2.1%)		1/44 (2.3%)		1/47 (2.1%)
Conjunctival hyperaemia, FELLOW EYE ONLY	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		2/48 (4.2%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Conjunctival hyperaemia, STUDY EYE ONLY	2/47 (4.3%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Conjunctival oedema, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Conjunctival oedema, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Conjunctival oedema, STUDY EYE ONLY	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Corneal deposits, BOTH EYES	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Corneal disorder, BOTH EYES	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Corneal disorder, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Corneal epithelium defect, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Corneal erosion, BOTH EYES	0/47 (0%)		2/46 (4.3%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Corneal oedema, STUDY EYE ONLY	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Dry eye, BOTH EYES	2/47 (4.3%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Erythema of eyelid, STUDY EYE ONLY	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Excessive eye blinking, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		1/47 (2.1%)
Eye disorder, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Eye irritation, BOTH EYES	1/47 (2.1%)		1/46 (2.2%)		1/47 (2.1%)		2/48 (4.2%)		2/48 (4.2%)		0/44 (0%)		1/47 (2.1%)
Eye irritation, FELLOW EYE ONLY	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Eye pain, BOTH EYES	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		1/48 (2.1%)		2/44 (4.5%)		1/47 (2.1%)
Eye pain, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Eye pruritus, BOTH EYES	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		2/44 (4.5%)		0/47 (0%)
Eye pruritus, FELLOW EYE ONLY	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Eye swelling, BOTH EYES	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Eyelid disorder, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Eyelid irritation, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Eyelid irritation, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Eyelid margin crusting, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Eyelid oedema, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Foreign body sensation in eyes, BOTH EYES	1/47 (2.1%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Iritis, BOTH EYES	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Lacrimation increased, BOTH EYES	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		2/47 (4.3%)
Lacrimation increased, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		2/47 (4.3%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Meibomian gland dysfunction, BOTH EYES	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		2/44 (4.5%)		0/47 (0%)
Meibomian gland dysfunction, FELLOW EYE ONLY	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		1/44 (2.3%)		1/47 (2.1%)
Meibomian gland dysfunction, STUDY EYE ONLY	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		1/44 (2.3%)		2/47 (4.3%)
Myodesopsia, FELLOW EYE ONLY	0/47 (0%)		1/46 (2.2%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Myodesopsia, STUDY EYE ONLY	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Ocular discomfort, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		1/47 (2.1%)
Ocular hyperaemia, BOTH EYES	0/47 (0%)		2/46 (4.3%)		1/47 (2.1%)		1/48 (2.1%)		1/48 (2.1%)		0/44 (0%)		1/47 (2.1%)
Ocular hyperaemia, STUDY EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Photophobia, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Punctate keratitis, BOTH EYES	1/47 (2.1%)		1/46 (2.2%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Punctate keratitis, STUDY EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Trichiasis, FELLOW EYE ONLY	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Vision blurred, BOTH EYES	1/47 (2.1%)		0/46 (0%)		1/47 (2.1%)		2/48 (4.2%)		2/48 (4.2%)		1/44 (2.3%)		1/47 (2.1%)
Visual acuity reduced, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Visual acuity reduced, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Visual acuity reduced, STUDY EYE ONLY	1/47 (2.1%)		0/46 (0%)		3/47 (6.4%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Visual impairment	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Visual impairment, BOTH EYES	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Gastrointestinal disorders
Abdominal discomfort	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Colitis ulcerative	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Diarrhoea	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Dry mouth	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Dyspepsia	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Nausea	2/47 (4.3%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Palatal disorder	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Vomiting	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
General disorders
Instillation site pain, BOTH EYES	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		1/48 (2.1%)		2/44 (4.5%)		3/47 (6.4%)
Instillation site pain, STUDY EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Instillation site pruritus, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Sensation of foreign body, FELLOW EYE ONLY	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Temperature intolerance, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Immune system disorders
Hypersensitivity, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Infections and infestations
Bronchiectasis	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Bronchitis	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Conjunctivitis bacterial, STUDY EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Ear infection	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Eyelid infection	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Fungal skin infection	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Gastroenteritis	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Gastroenteritis viral	0/47 (0%)		0/46 (0%)		0/47 (0%)		2/48 (4.2%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Localised infection	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Lower respiratory tract infection	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Perichondritis	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Respiratory tract infection	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Sinusitis	2/47 (4.3%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Tooth abscess	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Upper respiratory tract infection	0/47 (0%)		0/46 (0%)		3/47 (6.4%)		0/48 (0%)		0/48 (0%)		2/44 (4.5%)		1/47 (2.1%)
Urinary tract infection	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		0/48 (0%)		2/44 (4.5%)		1/47 (2.1%)
Viral pharyngitis	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Injury, poisoning and procedural complications
Animal bite	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Arthropod bite	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Contact lens complication, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Corneal abrasion, STUDY EYE ONLY	0/47 (0%)		1/46 (2.2%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Fall	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Foreign body trauma, FELLOW EYE ONLY	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Incision site pain	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Superficial injury of eye, STUDY EYE ONLY	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Wrist fracture	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Investigations
Blood cholesterol increased	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Blood glucose increased	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Blood triglycerides abnormal	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Blood triglycerides increased	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Urine analysis abnormal	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Metabolism and nutrition disorders
Gout	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Hyperglycaemia	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Hypokalaemia	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/47 (4.3%)		1/46 (2.2%)		1/47 (2.1%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Back pain	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Musculoskeletal pain	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Neck pain	1/47 (2.1%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Pain in extremity	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Rheumatoid arthritis	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Tendonitis	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Nervous system disorders
Amnesia	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)
Burning sensation, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		1/47 (2.1%)
Disturbance in attention	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Dizziness	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Headache	0/47 (0%)		2/46 (4.3%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Psychiatric disorders
Mood altered	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/47 (0%)		0/46 (0%)		0/47 (0%)		1/48 (2.1%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Sinus congestion	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Skin and subcutaneous tissue disorders
Dermatitis contact	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Telangiectasia, STUDY EYE ONLY	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Urticaria	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Social circumstances
Impaired work ability, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		1/47 (2.1%)
Surgical and medical procedures
Injection, BOTH EYES	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		1/48 (2.1%)		0/44 (0%)		0/47 (0%)
Vascular disorders
Hyperaemia	1/47 (2.1%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		0/47 (0%)
Hypertension	0/47 (0%)		0/46 (0%)		1/47 (2.1%)		0/48 (0%)		0/48 (0%)		1/44 (2.3%)		0/47 (0%)
Hypotension	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/48 (0%)		0/48 (0%)		0/44 (0%)		1/47 (2.1%)

Limitations/Caveats

In this study, a variance was made in the planned analysis. At the time of data analysis, results from Stage 1 and 2 were combined for efficacy and safety analyses. Hence, results are presented together for both stages.

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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.