Status:
COMPLETED
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Lead Sponsor:
Novartis
Conditions:
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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) pat...
Eligibility Criteria
Inclusion
- History of artificial tear use
- Moderate to severe signs of dry eye
- Moderate to severe ocular discomfort
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00128245
Start Date
September 1 2004
End Date
December 1 2006
Last Update
May 27 2020
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States