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...
Date First Received: August 5, 2005
Last Updated: December 19, 2007
Verified by: Novartis, December 2007
Clinical Trial Phase: N/A | Start Date: September 2004
Overall Status: Completed
Estimated Enrollment: 440
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Pimecrolimus
Outcome Measures for this Clinical Trial
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
Criteria for Participation 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 for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Gary Foulks, Dr. Principal Investigator University of Louisville, USA
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00128245
Study ID Number: CASM981E2205
ClinicalTrials.gov Identifier: NCT00128245
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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