NCT00128245CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Pimecrolimus 0.3%
Experimental
ASM981 0.3%
Intervention: Pimecrolimus (Drug)
Pimecrolimus 1%
Experimental
ASM981 1%
Intervention: Pimecrolimus (Drug)
Vehicle with carbopol
Placebo Comparator
Intervention: Vehicle (Drug)
Vehicle without carbopol
Placebo Comparator
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
Secondary Outcomes
- 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
- Global assessment of efficacy and tolerability
Investigators
Study Sites (1)
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