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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128245

Enrollment

440

Registered

2005-08-09

Start date

2004-09-30

Completion date

2006-12-31

Last updated

2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis Sicca

Keywords

KCS, dry eye, pimecrolimus, Keratoconjunctivitis sicca (dry eye syndrome)

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.

Interventions

DRUGPimecrolimus

DRUGVehicle

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms	—
Global assessment of efficacy and tolerability	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026