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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: December 2006

Interventions

  • Drug: Pimecrolimus
  • Drug: Vehicle
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Pimecrolimus 0.3%
    • ASM981 0.3%
  • Experimental: Pimecrolimus 1%
    • ASM981 1%
  • Placebo Comparator: Vehicle with carbopol
  • Placebo Comparator: Vehicle without carbopol

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 24 week’s treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
  • Global assessment of efficacy and tolerability

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gary Foulks, Dr., Principal Investigator, University of Louisville, USA

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