Clinical Trial: Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Patient
Brief 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.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome:
- 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)
Original Primary Outcome:
Current Secondary Outcome:
- 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
- Global assessment of efficacy and tolerability
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: August 5, 2005
Date Started: September 2004
Date Completion:
Last Updated: December 19, 2007
Last Verified: December 2007
