Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca - Full Text View

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

ChemIDplus related topics:

Pimecrolimus

U.S. FDA Resources

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

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

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

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

Keywords provided by Novartis:

KCS

dry eye

pimecrolimus

Keratoconjunctivitis sicca (dry eye syndrome)

Study placed in the following topic categories:

Corneal Diseases

Keratoconjunctivitis sicca

Xerophthalmia

Eye Diseases

Lacrimal Apparatus Diseases

Keratitis

Pimecrolimus

Dry Eye Syndromes

Conjunctivitis

Keratoconjunctivitis

Conjunctival Diseases

Keratoconjunctivitis Sicca

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on September 05, 2008

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