Phase 2
Completed N=285
A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT01135511 ↗
Enrolled (actual)
285
Serious AEs
1.1%
Results posted
May 2013
Primary outcomePrimary: Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 — -3.0; -3.0; -3.0; -3.1 Units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 |
-3.0; -3.0; -3.0; -3.1; -3.2; -2.4 | — |
| SECONDARY Changes in Corneal Staining Scores for Study Eye From Baseline |
-2.1; -1.9; -1.9; -1.6; -2.0; -2.4 | — |
| SECONDARY Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye |
4.9; 2.4; 5.0; 0; 0; 2.5 | — |
| SECONDARY Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline |
-0.8; -0.7; -0.6; -1.1; -0.6; -1.0 | — |
| SECONDARY Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline |
0.04; 0.43; 0.19; 0.22; 0.43; 0.09 | — |
| SECONDARY Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline |
0.78; 0.34; 0.01; 0.08; 0.71; 0.28 | — |
| SECONDARY Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye |
7.3; 4.9; 0; 2.5; 7.7; 2.5 | — |
| SECONDARY Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye |
2; 1; 0; 1; 1; 0 | — |
| SECONDARY Changes in the Ocular Comfort Index (OCI) Total Score From Baseline |
-1.94; -2.00; -2.13; -4.17; -3.14; -4.16 | — |
| SECONDARY Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline |
17; 15; 13; 21; 16; 19 | — |
| SECONDARY Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline |
-0.43; -3.87; -0.67; -5.00; -2.99; -4.09 | — |
| SECONDARY Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms |
-0.81; -4.07; -3.96; -5.00; -2.56; -4.17 | — |
| SECONDARY Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function |
-0.36; -4.71; 0.40; -6.55; -3.33; -2.61 | — |
| SECONDARY Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers |
1.21; -4.28; 0.31; -3.53; -4.88; -6.53 | — |
| SECONDARY Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline |
14.6; 24.4; 12.5; 22.5; 20.5; 32.5 | — |
| SECONDARY Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye |
8; 4; 6; 5; 1 | — |
| SECONDARY Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye |
8; 6; 2; 4; 7 | — |
| SECONDARY Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores |
31; 29; 30; 35; 28 | — |
| SECONDARY Number of Participants With Ocular Adverse Events (AEs)by Severity |
4; 0; 4; 2; 2; 3 | — |
| SECONDARY Number of Participants With Nonocular Adverse Events (AEs) by Severity |
7; 12; 10; 10; 8; 2 | — |
| SECONDARY Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale |
32; 33; 32; 32; 36; 11 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01135511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.