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

Novartis1 site in 1 country440 target enrollmentSeptember 2004

ConditionsKeratoconjunctivitis Sicca

InterventionsPimecrolimus Vehicle

DrugsPimecrolimus Vehicle

Overview

Phase: Phase 2
Intervention: Pimecrolimus
Conditions: Keratoconjunctivitis Sicca
Sponsor: Novartis
Enrollment: 440
Locations: 1
Primary Endpoint: change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

December 2006

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

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.