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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