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

Allergan781 enrolled

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

OBSERVATIONAL

Enrollment

781

Conditions

Keratoconjunctivitis Sicca

Interventions

cyclosporine ophthalmic emulsion 0.05%, artificial tearsDRUG

one drop, twice a day in each eye

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Wilson, North Carolina, United States

Outcomes

Primary Outcomes

Ocular Surface Disease Index (OSDI) Total Score at 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).

Time frame: Baseline

Data from ClinicalTrials.gov

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