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

Novartis440 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

440

Conditions

Keratoconjunctivitis Sicca

Interventions

PimecrolimusDRUG

VehicleDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom

change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)

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

Data from ClinicalTrials.gov

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