Original ArticlePhase III Safety Evaluation of Cyclosporine 0.1% Ophthalmic Emulsion Administered Twice Daily to Dry Eye Disease Patients for Up to 3 Years
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Materials and Methods
This study was a multicenter open-label extension of two 12-month phase III clinical trials of ophthalmic cyclosporine.11 Institutional review board/ethics committee approval was obtained before the extension study. The previous phase III clinical trials included patients with moderate to severe keratoconjunctivitis sicca who were treated with cyclosporine 0.05% emulsion or cyclosporine 0.1% emulsion for 6 to 12 months.11 (Patients who were treated with cyclosporine for 6 months in the phase
Results
Demographic data are presented in Table 1. The mean age of the 412 participants was 59.4 years, 80.3% were female, and 85.7% were Caucasian.
Of the 412 patients enrolled in the first 12-month extension period, 328 (79.6%) completed it (Table 2). Similarly, 71.9% (138/192) of the patients enrolled in the second extension period completed it, 60.8% (76/125) of the patients enrolled in the third extension period completed it, and 20.8% (26/125) of those enrolled in the third extension period were
Discussion
This trial consisted of 3 consecutive 12-month periods of treatment with cyclosporine 0.1% ophthalmic emulsion instilled twice daily. Treatment during the first 12-month period resulted in modest improvements in objective measures of dry eye disease and no change in subjective measures, which was expected because participants had been treated with cyclosporine emulsion (either 0.05% or 0.1%) for 6 to 12 months before the baseline assessment of this study.11
Adverse event frequencies during this
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Manuscript no. 2004-355.
Research funded by Allergan Inc., Irvine, California.
The authors have no financial interest in the treatment investigated in this study. However, all 4 authors serve on speakers’ bureaus and have received research funding from Allergan Inc., the manufacturer of cyclosporine 0.0 5% ophthalmic solution (Restasis), a product closely related to the treatment used in this study.