Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
- Study Primary Completion Date: December 2006
Interventions
- Drug: Pimecrolimus
- Drug: Vehicle
- Placebo
Arms, Groups and Cohorts
- Experimental: Pimecrolimus 0.3%
- ASM981 0.3%
- Experimental: Pimecrolimus 1%
- ASM981 1%
- Placebo Comparator: Vehicle with carbopol
- Placebo Comparator: Vehicle without carbopol
Clinical Trial Outcome Measures
Primary Measures
- 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)
Secondary Measures
- 24 week’s treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
- Global assessment of efficacy and tolerability
Participating in This Clinical Trial
Inclusion Criteria
- History of artificial tear use – Moderate to severe signs of dry eye – Moderate to severe ocular discomfort Exclusion Criteria:
- Patients with uncontrolled systemic or ocular diseases. – Have any history of refractive surgery – Use any topical ocular medications other than those dispensed for the study, during the study Other protocol-defined exclusion criteria may apply.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Novartis
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Gary Foulks, Dr., Principal Investigator, University of Louisville, USA
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