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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128245
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : December 28, 2007
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Brief Summary:
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 or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: Pimecrolimus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
  2. change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)

Secondary Outcome Measures :
  1. 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
  2. Global assessment of efficacy and tolerability

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128245

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

Layout table for additonal information Identifier: NCT00128245    
Other Study ID Numbers: CASM981E2205
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007
Keywords provided by Novartis:
dry eye
Keratoconjunctivitis sicca (dry eye syndrome)
Additional relevant MeSH terms:
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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
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action