Safety and efficacy of cyclosporine 0.05% drops versus unpreserved artificial tears in dry-eye patients having laser in situ keratomileusis

PURPOSE: To evaluate dry-eye signs, symptoms, and refractive outcomes in patients with dry-eye disease having laser in situ keratomileusis (LASIK). METHODS: In this randomized parallel double-masked prospective clinical trial, 42 eyes of 21 myopic patients (mean spherical equivalent −4.3 diopters [D], range −1.00 to −10.63 D) with dry-eye disease were treated with unpreserved artificial tears or cyclosporine 0.05% ophthalmic emulsion twice a day beginning 1 month before LASIK. Treatment with the study drug was discontinued for 48 hours post surgery and then resumed for 3 additional months. Both groups used additional artificial tears as needed. Study visits occurred pretreatment (baseline), before surgery, and at 1 week and 1, 3, 6, and 12 months after surgery. RESULTS: Statistically significant increases from baseline were found in Schirmer scores for artificial tears at 1 month (P = .036) and for cyclosporine 0.05% before surgery and 1 week, 1 month, and 6 months after surgery (P<.018). There were no significant differences from baseline or between groups in responses to the Ocular Surface Disease Index questionnaire or best corrected visual acuity (BCVA), nor were there significant between-group differences in superficial punctate keratitis or uncorrected visual acuity. Mean refractive spherical equivalent in cyclosporine-treated eyes was significantly closer to the intended target at 3 and 6 months after surgery than in artificial-tears–treated eyes (P = .007). A greater percentage of cyclosporine eyes was within ±0.5 D of the refractive target 3 months after surgery than artificial tears eyes (P = .015). CONCLUSION: Successful outcomes after LASIK were achieved for dry-eye disease patients. Treatment with cyclosporine 0.05% provided greater refractive predictability 3 and 6 months after surgery than unpreserved artificial tears.