Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

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: NCT00717418
Recruitment Status : Completed
First Posted : July 17, 2008
Results First Posted : January 12, 2012
Last Update Posted : January 12, 2012
Information provided by (Responsible Party):

Brief Summary:
This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

Condition or disease Intervention/treatment
Keratoconjunctivitis Sicca Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

Study Type : Observational
Actual Enrollment : 781 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Group/Cohort Intervention/treatment
  • cyclosporine ophthalmic emulsion 0.05%
  • artificial tears
Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears
one drop, twice a day in each eye
Other Name: Restasis®

Primary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) Total Score at Baseline [ Time Frame: Baseline ]
    The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients can either:

  1. be newly diagnosed or changing therapies and require, in the judgment of the treating physician, a prescription treatment
  2. have insufficiently controlled dry eye symptoms necessitating use of over-the-counter treatments

Inclusion Criteria:

  • Diagnosis of dry eye disease
  • Currently using artificial tears daily
  • Male or female of legal age of consent
  • Normal lid position and closure

Exclusion Criteria

  • Patients currently using cyclosporine ophthalmic emulsion 0.05%
  • Participation in other investigational drug or device study
  • Any current or previous topical ophthalmic or oral cyclosporine use within the last three years

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): NCT00717418

United States, North Carolina
Wilson, North Carolina, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan

Responsible Party: Allergan Identifier: NCT00717418     History of Changes
Other Study ID Numbers: R.E.S.T.O.R.E.
First Posted: July 17, 2008    Key Record Dates
Results First Posted: January 12, 2012
Last Update Posted: January 12, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Lubricant Eye Drops
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Ophthalmic Solutions
Pharmaceutical Solutions