Clinical trial NCT01226680: A Study Of Tasocitinib In Dry Eye Subjects
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye
Schirmer test
corneal staining
OSDI
OCI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in length of wetting of Schirmer test strip without anesthesia from baseline
timeFrame: Week 12
measure: Change in Ocular Surface Disease Index's Environmental Trigger (OSDI-ET) subscale score from baseline
timeFrame: Week 12
Secondary outcomes:
measure: Systemic safety: adverse events, clinical laboratory; and vital signs
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: staining
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: ≥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
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: