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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00128245

First received: August 5, 2005

Last updated: December 19, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2005

Last Updated Date

December 19, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00128245 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Keratoconjunctivitis Sicca

Intervention ^ICMJE

Drug: Pimecrolimus

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

440

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00128245

Other Study ID Numbers ^ICMJE

CASM981E2205

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gary Foulks, Dr.

University of Louisville, USA

Information Provided By

Novartis

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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