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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00717418
First received: July 14, 2008
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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 Intervention
Keratoconjunctivitis Sicca
Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Ocular Surface Disease Index (OSDI) Total Score at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).


Enrollment: 781
Study Start Date: September 2004
Study Completion Date: August 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
  • 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®

  Eligibility

Genders Eligible for Study:   Both
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
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717418

Locations
United States, North Carolina
Wilson, North Carolina, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00717418     History of Changes
Other Study ID Numbers: R.E.S.T.O.R.E.
Study First Received: July 14, 2008
Results First Received: December 5, 2011
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 16, 2014