A Study Of Tasocitinib In Dry Eye Subjects

Study Overview
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Brief Summary
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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.

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

Conditions
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Keratoconjunctivitis Sicca

Intervention / Treatment
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* Drug: Tasocitinib
* Drug: Tasocitinib
* Drug: vehicle for Tasocitinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tasocitinib 0.005% QD<br> | Drug: Tasocitinib<br>* 0.005% QD for 12 weeks<br>|
| Experimental: Tasocitinib 0.003% QD<br> | Drug: Tasocitinib<br>* 0.003% QD for 12 weeks<br>|
| Placebo Comparator: Vehicle for Tasocitinib<br> | Drug: vehicle for Tasocitinib<br>* vehicle QD for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Schirmer test, corneal staining, OSDI, OCI