Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
- Registration Number
- NCT00128245
- Lead Sponsor
- Novartis
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pimecrolimus 0.3% Pimecrolimus ASM981 0.3% Pimecrolimus 1% Pimecrolimus ASM981 1% Vehicle with carbopol Vehicle - Vehicle without carbopol Vehicle -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms Global assessment of efficacy and tolerability
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States
Novartis🇺🇸East Hanover, New Jersey, United States