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Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group
Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group.
Main finding: Cyclosporin A 0.05% and 0.1% were safe and effective in the treatment of moderate to severe dry eye disease, with improvement of both objective and subjective measures.
Purpose: To compare the efficacy and safety of cyclosporin A (0.05% and 0.1% ophthalmic emulsions) to vehicle in patients with moderate to severe dry eye disease.
Study type: Randomized controlled Trial
Condition: Dry Eye Disease
Participants:
Moderate to severe dry eye disease
n=877
Intervention:
Group 1: Cyclosporin A ophthalmic emulsion (0.05%)
Group 2: Cyclosporin A ophthalmic emulsion (0.1%)
Group 3: placebo
Cyclosporin A 0.05% and 0.1%, gave significantly greater improvements then vehicle in:
objective signs:
corneal staining and categorized Schirmer values
subjective measures:
blurred vision, need for concomitant artificial tears, and the physician’s evaluation of global
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