A Phase I/II Prospective, Randomized, Double Masked, Vehicle And Comparator Controlled, Dose Ranging Study Of CP-690,550 In Subjects With Dry Eye Disease.
Overview
- Phase
- Phase 1
- Intervention
- CP-690,550
- Conditions
- Dry Eye Syndromes
- Sponsor
- Pfizer
- Enrollment
- 327
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Systemic Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptoms of dry eye for at least 6 months.
- •Signs of moderate to severe dry eye
Exclusion Criteria
- •Women who are nursing or pregnant
- •Participation in other studies within 30 days of screening visit
- •Ocular disorders that may confound interpretation of study results
Arms & Interventions
Treatment 2
Intervention: CP-690,550
Treatment 1
Intervention: CP-690,550
Treatment 3
Intervention: CP-690,550
Treatment 4
Intervention: CP-690,550
Active comparator
Intervention: Cyclosporine
Placebo
Intervention: CP-690,550 Vehicle
Outcomes
Primary Outcomes
Percentage of Participants With Systemic Adverse Events (AEs)
Time Frame: Baseline up to Week 8
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Percentage of Participants With Ocular Adverse Events (AEs)
Time Frame: Baseline up to Week 8
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
Percentage of Participants With Ocular Tolerability Assessment
Time Frame: Baseline up to Week 8
Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application).
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
Time Frame: Week 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Secondary Outcomes
- Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia(Baseline through Week 8)
- Time to Achieve 100 Percent (%) Clearance of Corneal Staining(Baseline through Week 8)
- Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score(Baseline through Week 8)
- Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8(Baseline, Week 8)
- Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6(Week 1, 2, 4, 6)
- Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8(Week 8)
- Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining(Week 1, 2, 4, 6, 8)
- Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Percentage of Participants With >= 5 Units Decrease in Total OCI Score(Week 1, 2, 4, 6, 8)
- Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Percentage of Participants With >= 10 Units Decrease in Total OSDI Score(Week 1, 2, 4, 6, 8)
- Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8(Baseline, Week 8)