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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:


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:
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