Trials / Completed
CompletedNCT00128245
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 440 (planned)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pimecrolimus | |
| DRUG | Vehicle | Placebo |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2006-12-01
- Completion
- 2006-12-01
- First posted
- 2005-08-09
- Last updated
- 2020-05-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00128245. Inclusion in this directory is not an endorsement.