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

This study has been completed.

Sponsored by: 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

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




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