Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca

Completed · Phase 2 · Has a placebo group

Conditions studied: Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID

NCT00128245

Run by

Novartis

People needed

440

Starts

2004-09-01

Expected to finish

2006-12-01

Last updated by the study team

2020-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of artificial tear use
• Moderate to severe signs of dry eye
• Moderate to severe ocular discomfort

You may not qualify if…

• 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.

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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