A Study Of Tasocitinib In Dry Eye Subjects

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01226680

Collaborator

(none)

Enrollment

Arms

22.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib (CP-690,550) in the subjects with moderate to severe dry eye disease. Both subjective and objective clinical endpoints will be measured for a duration of 12-week treatment.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca	Drug: Tasocitinib Drug: Tasocitinib Drug: vehicle for Tasocitinib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase II, Randomized, Double Masked, Parallel Group, Vehicle Controlled, Multiple-Dose Study Of Tasocitinib (CP-690,550) In Subjects With Dry Eye Disease

Actual Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Oct 19, 2012

Anticipated Study Completion Date :

Oct 19, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tasocitinib 0.005% QD	Drug: Tasocitinib 0.005% QD for 12 weeks
Experimental: Tasocitinib 0.003% QD	Drug: Tasocitinib 0.003% QD for 12 weeks
Placebo Comparator: Vehicle for Tasocitinib	Drug: vehicle for Tasocitinib vehicle QD for 12 weeks

Arm

Intervention/Treatment

Experimental: Tasocitinib 0.005% QD

Drug: Tasocitinib

0.005% QD for 12 weeks

Experimental: Tasocitinib 0.003% QD

Drug: Tasocitinib

0.003% QD for 12 weeks

Placebo Comparator: Vehicle for Tasocitinib

Drug: vehicle for Tasocitinib

vehicle QD for 12 weeks

Outcome Measures

Primary Outcome Measures

Change in length of wetting of Schirmer test strip without anesthesia from baseline [Week 12]
Change in Ocular Surface Disease Index's Environmental Trigger (OSDI-ET) subscale score from baseline [Week 12]

Secondary Outcome Measures

Systemic safety: adverse events, clinical laboratory; and vital signs [12 weeks]
Ocular tolerability and safety: incidence and severity of ocular adverse events during the study (ophthalmic examination, ocular tolerability assessment and/ or adverse events spontaneously reported) [12 weeks]
Schirmer test without anesthesia: Change in length of wetting from baseline at Days 7, 14, 28, and Week 8; Response rate (percentage of subjects who achieve ≥10mm wetting) at Days 7, 14, 28, and Weeks 8 and 12; Response rate (percentage of [12 weeks]
subjects who achieve increase of ≥10mm wetting) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of change from baseline of ≥10mm wetting;Time to achievement of ≥10mm wetting [12 weeks]
Corneal staining:Change from baseline at Days 7, 14, 28 and Weeks 8 and 12;Response rate (percentage of subjects who demonstrate 100% clearing of corneal staining) at Days 7, 14, 28 and Weeks 8 and 12;Time to achievement of 100% clearing of corneal [12 weeks]
staining [12 weeks]
Ocular Surface Disease Index (OSDI): Change in the OSDI total score and three subscale scores (the Ocular Symptoms, Vision-Related Function, and Environmental Triggers) from baseline at Days 7, 14, 28, and Weeks 8 and 12 (except ET subscale [12 weeks]
score); Response rate (percentage of subjects who demonstrating ≥10 unit decrease in OSDI total score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of ≥10 unit decrease in OSDI total score [12 weeks]
Modified Ocular Comfort Index (mOCI): Change in the OCI score, the Dry Eye Symptoms (DES) and Symptom Interference (SI) subscales scores from baseline at Days 7, 14, 28 and Weeks 8 and 12; OCI Response rate (percentage of subjects who demonstrating [12 weeks]
≥3 point decrease from baseline in the OCI score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of ≥3 point decrease from baseline in the OCI score [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and females aged 18 years or older at time of consent
Diagnosis of dry eye disease, characterized by subjective symptoms of dry eye for at least 6 months, Schirmer test without anesthesia: =>1 mm and =<7 mm, sum of corneal fluorescein staining score of =>4 (NEI Scale), and subject grading total score of => 23 on the OSDI

Exclusion Criteria:

Planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of the Screening visit or during study
Ocular disorders that may confound interpretation of study results such as significant corneal surface disease not caused by dry eyes, abnormal corneal sensitivity, abnormal tear spreading, including but not limited to the following: abnormal lid function, lid position, or blink rate, that in the opinion of the investigator is clinically significant, history of herpetic keratopathy
Lacrimal punctal occlusion (plugs or cautery) within 2 months of the Screening visit
Contact lens wear within 2 weeks of the Screening visit and/or during study participation.