NCT01135511CompletedPhase 2
A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Study Overview
Brief Summary
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjective symptoms of dry eye for at least 6 months
- •Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)
Exclusion Criteria
- •Women who are nursing, pregnant or planning pregnancy during the study
- •Participation in other studies within 30 days of screening visit
- •Ocular disorders that may confound interpretation of study results
Arms & Interventions
Treatment 5
Active Comparator
Intervention: Sodium Hyaluronate (Drug)
Treatment 2
Experimental
Intervention: CP-690,550 Eye drops (Drug)
Treatment 1
Experimental
Intervention: CP-690,550 Eye drops (Drug)
Treatment 4
Placebo Comparator
Intervention: CP-690,550 Eye drops-vehicle (Drug)
Treatment 3
Experimental
Intervention: CP-690,550 Eye drops (Drug)
Outcomes
Primary Outcomes
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Time Frame: Baseline, Week 8
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Secondary Outcomes
- Changes in Corneal Staining Scores for Study Eye From Baseline(Baseline, Week 1, 2 and 4)
- Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye(Week 1, 2, 4 and 8)
- Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline(Baseline, Week 1, 2, 4 and 8)
- Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline(Baseline, Week 1, 2, 4 and 8)
- Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline(Baseline, Week 1, 2, 4 and 8)
- Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye(Week 1, 2, 4 and 8)
- Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye(Week 1, 2, 4 and 8)
- Changes in the Ocular Comfort Index (OCI) Total Score From Baseline(Baseline, Week 1, 2, 4 and 8)
- Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline(Week 1, 2, 4 and 8)
- Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline(Baseline, Week 1, 2, 4 and 8)
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms(Baseline, Week 1, 2, 4 and 8)
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function(Baseline, Week 1, 2, 4 and 8)
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers(Baseline, Week 1, 2, 4 and 8)
- Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline(Week 1, 2, 4 and 8)
- Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye(Week 8)
- Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye(Week 8)
- Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores(Week 8)
- Number of Participants With Ocular Adverse Events (AEs)by Severity(8 weeks)
- Number of Participants With Nonocular Adverse Events (AEs) by Severity(8 weeks)
- Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale(8 weeks)
Investigators
Study Sites (1)
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