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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2006

Interventions

  • Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears
    • one drop, twice a day in each eye

Arms, Groups and Cohorts

  • 1
    • cyclosporine ophthalmic emulsion 0.05% artificial tears

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Allergan

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