Last reviewed · How we verify
A 24-week Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Evaluation of the Safety and Efficacy of 0.3% and 1% Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients With Moderate to Severe Keratoconjunctivitis Sicca
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 440 |
| Start date | 2004-09 |
| Completion | 2006-12 |
Conditions
- Keratoconjunctivitis Sicca
Interventions
- Pimecrolimus
- Vehicle
Primary outcomes
- 12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
- change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
Countries
United States