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H.D. Perry, S. Doshi, E.D. Donnenfeld, S.A. Biser, A.H. Bloom; Double Masked Randomized Controlled Study Evaluating Topical 0.05% Cyclosporine A in the Treatment of Meibomian Gland Dysfunction (Posterior Blepharitis) . Invest. Ophthalmol. Vis. Sci. 2003;44(13):1395.
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Purpose: To test the efficacy of topical Cyclosporine A 0.05% (tCSA) in the treatment of meibomian gland dysfunction (posterior blepharitis). Methods: 33 patients with symptomatic meibomian gland dysfunction (posterior blepharitis) were randomized to either tCSA or placebo, Refresh Preservative-Free (RPF), bid for 3 months. The study was double masked and the results were evaluated by a masked statistician. All patients were tested for ocular symptoms, Snellen visual acuity, intraocular pressure (IOP), lid margin vascularity, tarsal telangiectasis, bulbar conjunctival hyperemia, tarsal papillary hypertrophy, meibomian gland inclusions, corneal neovascularization, corneal infiltrates, tear secretion (Schirmer I), tear break-up time, fluorescein staining and lissamine green staining. They were evaluated at baseline, one month, two months and three months. For statistical analysis only the 3 month data was analyzed. Results: 26 patients completed the study. Seven patients exited the study. In the tCSA group, two patients were discontinued for non-compliance with protocol, and two were discontinued because of discomfort after instilling the drops. 3 patients in the RPF group were discontinued because of non-compliance. Ocular symptoms at the 3 month visit improved in both the tCSA and RPF groups. The tCSA group showed a larger improvement in ocular symptoms than the RPF group, but this difference was not statistically significant. At the 3 month visit, several objective exam findings were better in the tCSA group than in the RPF group.These differences were statistically significant (p<0.05) for lid margin vascular injection, tarsal telangiectasis, and fluorescein staining. The most significant finding (p<0.001) was an observed decrease in meibomian gland inclusions in the tCSA group. There was no difference in visual acuity, intraocular pressure, tear secretion, or corneal infiltrates in either group. Tear break-up time and lissamine green staining trended in favor of the tCSA at the 3 month visit but were not stastistically significant. Conclusions: Topical Cyclosporine A 0.05% may be helpful in the treatment of meibomian gland dysfunction (posterior blepharitis). Topical Cyclosporine A 0.05% decreases the meibomian gland inclusions in patients with meibomian gland dysfunction. :
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