Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
NCT00128245 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 440
Last updated 2020-05-27
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
- Keratoconjunctivitis Sicca
Interventions
- DRUG
-
Pimecrolimus
- DRUG
-
Vehicle
Placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gary Foulks, Dr. · University of Louisville, USA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2006-12-31
- Completion
- 2006-12-31
Countries
- United States
Study Locations
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