The abstract does not tell us how many participants there were, and the authors are conscientious about acknowledging that the "small sample size" may have affected the results. Not that they ought to feel obliged to be apologetic about not reporting better results! But seriously, it is not easy to go against the grain of published literature, which is overwhelmingly pro Restasis.
While this study is "about" contact lens wearers, note that it was NOT attempting to measure their contact lens comfort. It was measuring their dry eye signs and symptoms. It kind of struck me as a subtle back door way of really saying, "Here's a broad spectrum group of people for whom Restasis did nothing". The more obvious message of the study, of course, is that all those physicians who refuse to stray from the path of pharmacological treatment for ocular surface disease even where other treatment is clearly indicated by lid margin disease, nocturnal lagophthalmos, BAK toxicity or what have you, not to mention chronic contact lens overwear, should not look to Restasis as the magic bullet for contact lens tolerance problems. Not that I hold out hope of that message taking hold, mind you. After all, this is an industry that indirectly touts laser refractive surgeries as a solution for contact lens intolerance. Sigh.
Efficacy of Cyclosporine 0.05% Ophthalmic Emulsion in Contact Lens Wearers With Dry Eyes.
Willen CM, McGwin G, Liu B, Owsley C, Rosenstiel C
Eye Contact Lens. 2008 Jan;34(1):43-45
PURPOSE.: To assess the efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis; Allergan, Inc., Irvine, CA) in the treatment of contact lens wearers with dry eyes.
METHODS.: Contact lens wearers citing dry eye problems were identified through chart review. Participants were randomly assigned to a treatment group, receiving vials of cyclosporine 0.05% ophthalmic emulsion to use twice daily, or a placebo group, receiving vials of rewetting drops (Refresh Preservative Free Artificial Tears; Allergan, Inc.) to use twice daily. Corneal staining, tear film breakup time, and Schirmer test results were documented at baseline and after 3 months. Participants also completed questionnaires, the Ocular Surface Disease Index, and the National Eye Institute Refractive Error Quality of Life Instrument at baseline and after 3 months.
RESULTS.: For all parameters, including objective findings and subjective reporting of symptoms, there was no statistically significant difference between the treatment and placebo groups.
CONCLUSIONS.: This study did not detect a beneficial effect in using cyclosporine 0.05% ophthalmic emulsion over rewetting drops for contact lens wearers. This may be attributable to the small sample size. It is also possible that the mechanism of the dry eye state in contact lens wearers may be different from that of other dry eye states and thus make cyclosporine 0.05% ophthalmic emulsion an ineffective treatment.
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