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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00128245
First received: August 5, 2005
Last updated: December 19, 2007
Last verified: December 2007
  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: 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov 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:
KCS
dry eye
pimecrolimus
Keratoconjunctivitis sicca (dry eye syndrome)

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on July 20, 2014