A Study Of Tasocitinib In Dry Eye Subjects

Phase 2

Withdrawn

• Conditions: Keratoconjunctivitis Sicca
• Interventions: Drug: Tasocitinib; Drug: vehicle for Tasocitinib

• Registration Number: NCT01226680
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-22
• Study Start: 2010-12-01
• Primary Completion: 2012-10-19
• Study Completion: 2012-10-19
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tasocitinib 0.003% QD	Tasocitinib	-
Tasocitinib 0.005% QD	Tasocitinib	-
Vehicle for Tasocitinib	vehicle for Tasocitinib	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Systemic safety: adverse events, clinical laboratory; and vital signs	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
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
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
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
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