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

Novartis

Status and phase: Completed; Phase 2

Conditions: Keratoconjunctivitis Sicca

Treatments: Drug: Pimecrolimus; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00128245

CASM981E2205

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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 exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 4 patient groups, including a placebo group

Pimecrolimus 0.3%

Experimental group

Description:

ASM981 0.3%

Treatment:

Drug: Pimecrolimus

Pimecrolimus 1%

Experimental group

Description:

ASM981 1%

Treatment:

Drug: Pimecrolimus

Vehicle with carbopol

Placebo Comparator group

Treatment:

Drug: Vehicle

Vehicle without carbopol

Placebo Comparator group

Treatment:

Drug: Vehicle