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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 5, 2005
Last updated: December 19, 2007
Last verified: December 2007

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:

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

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

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 identifier: NCT00128245

United States, New Jersey
East Hanover, New Jersey, United States
Sponsors and Collaborators
Principal Investigator: Gary Foulks, Dr. University of Louisville, USA
  More Information

Additional Information:
No publications provided 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:
dry eye
Keratoconjunctivitis sicca (dry eye syndrome)

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on April 15, 2014