Clinical Trial: A Study Of Tasocitinib In Dry Eye Subjects

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:
Sponsor: Pfizer

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Systemic safety: adverse events, clinical laboratory; and vital signs [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]
  • staining [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: October 20, 2010
Date Started: December 2010
Date Completion: November 2011
Last Updated: December 21, 2010
Last Verified: December 2010