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Clinical Trials/NCT00128245
NCT00128245CompletedPhase 2

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

Novartis1 site in 1 country440 target enrollmentStarted: September 2004Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Novartis
Enrollment
440
Locations
1
Primary Endpoint
change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Pimecrolimus 0.3%

Experimental

ASM981 0.3%

Intervention: Pimecrolimus (Drug)

Pimecrolimus 1%

Experimental

ASM981 1%

Intervention: Pimecrolimus (Drug)

Vehicle with carbopol

Placebo Comparator

Intervention: Vehicle (Drug)

Vehicle without carbopol

Placebo Comparator

Intervention: Vehicle (Drug)

Outcomes

Primary Outcomes

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

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

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

Investigators

Sponsor
Novartis
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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