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

This study has been completed.

First Received on August 5, 2005. Last Updated on December 19, 2007 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00128245

Purpose

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.

Condition	Intervention
Keratoconjunctivitis Sicca	Drug: Pimecrolimus

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

Resource links provided by NLM:

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome 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 Outcome 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

Estimated Enrollment:	440
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128245

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Gary Foulks, Dr.

University of Louisville, USA

More Information

Additional Information:

Novartis patient recruitment website This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00128245 History of Changes
Other Study ID Numbers:	CASM981E2205
Study First Received:	August 5, 2005
Last Updated:	December 19, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

KCS
dry eye
pimecrolimus
Keratoconjunctivitis sicca (dry eye syndrome)

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012