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

This study has been completed.

First Received: August 5, 2005 Last Updated: 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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Study ID Numbers:	CASM981E2205
Study First Received:	August 5, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00128245 History of Changes
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:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Tacrolimus
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents
Keratoconjunctivitis Sicca
Corneal Diseases

Eye Diseases
Pimecrolimus
Conjunctivitis
Keratoconjunctivitis
Immunosuppressive Agents
Conjunctival Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Keratitis
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009