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NCT00128245 Clinical Trial

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

Keratoconjunctivitis Sicca Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00128245
Other study ID # CASM981E2205
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2004
Est. completion date December 2006

Study information
Verified date January 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 440
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pimecrolimus

• Vehicle
Placebo

Locations
Country Name City State
United States Novartis East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
Primary change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
Secondary 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
Secondary Global assessment of efficacy and tolerability
See also
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