PURPOSE: To evaluate the effect of cyclosporine 0.05% ophthalmic emulsion (Restasis, Allergan, Inc., Irvine, CA) on contact lens comfort and reducing dry eye symptoms in patients with contact lens intolerance. METHODS: A 5-week, randomized, investigator-masked study of 17 patients with self-reported contact lens-related dryness. Patients were randomized to cyclosporine twice per day or rewetting drops (carboxymethylcellulose 0.5%, Refresh Contacts) twice per day, to be used before and after lens wear. Changes from baseline in fluorescein staining of the cornea and conjunctiva and in tear breakup time were used to determine improvement of dry eye signs. Symptoms were assessed by lens wear time, use of rewetting drops during lens wear, subjective evaluation of dryness, and the completion of the Ocular Surface Disease Index questionnaire. RESULTS: Five weeks of cyclosporine treatment significantly improved dry eye symptoms (mean improvement of 0.88 +/- 0.64 with cyclosporine; no change of 0 +/- 0.58 [P = 0.01] with rewetting drops). Patients using cyclosporine decreased the use of rewetting drops by a mean 1.0 +/- 1.1 drops per day, and patients using rewetting drops increased their use (mean increase of 0.86 +/- 1.1 drops per day [P = 0.032]). Wearing time increased 1.9 +/- 2.1 hours per day with cyclosporine and 0.93 +/- 1.0 hours per day with rewetting drops (P = 0.258). There were no significant differences in mean corneal staining between groups. After 5 weeks, patients using cyclosporine showed statistically better improvements in temporal bulbar conjunctival fluorescein staining (decrease of 0.63 +/- 0.52 vs. increase of 0.57 +/- 0.67 [P = 0.002]) than patients using rewetting drops. Both treatments were tolerated well. CONCLUSIONS: The results of this pilot study indicate that cyclosporine 0.05% is beneficial for contact lens wearers with dry eye and reduces contact lens intolerance.
RCT Entities:
PURPOSE: To evaluate the effect of cyclosporine 0.05% ophthalmic emulsion (Restasis, Allergan, Inc., Irvine, CA) on contact lens comfort and reducing dry eye symptoms in patients with contact lens intolerance. METHODS: A 5-week, randomized, investigator-masked study of 17 patients with self-reported contact lens-related dryness. Patients were randomized to cyclosporine twice per day or rewetting drops (carboxymethylcellulose 0.5%, Refresh Contacts) twice per day, to be used before and after lens wear. Changes from baseline in fluorescein staining of the cornea and conjunctiva and in tear breakup time were used to determine improvement of dry eye signs. Symptoms were assessed by lens wear time, use of rewetting drops during lens wear, subjective evaluation of dryness, and the completion of the Ocular Surface Disease Index questionnaire. RESULTS: Five weeks of cyclosporine treatment significantly improved dry eye symptoms (mean improvement of 0.88 +/- 0.64 with cyclosporine; no change of 0 +/- 0.58 [P = 0.01] with rewetting drops). Patients using cyclosporine decreased the use of rewetting drops by a mean 1.0 +/- 1.1 drops per day, and patients using rewetting drops increased their use (mean increase of 0.86 +/- 1.1 drops per day [P = 0.032]). Wearing time increased 1.9 +/- 2.1 hours per day with cyclosporine and 0.93 +/- 1.0 hours per day with rewetting drops (P = 0.258). There were no significant differences in mean corneal staining between groups. After 5 weeks, patients using cyclosporine showed statistically better improvements in temporal bulbar conjunctival fluorescein staining (decrease of 0.63 +/- 0.52 vs. increase of 0.57 +/- 0.67 [P = 0.002]) than patients using rewetting drops. Both treatments were tolerated well. CONCLUSIONS: The results of this pilot study indicate that cyclosporine 0.05% is beneficial for contact lens wearers with dry eye and reduces contact lens intolerance.
Authors: Karl G Stonecipher; Gail L Torkildsen; George W Ousler; Scot Morris; Linda Villanueva; David A Hollander Journal: Clin Ophthalmol Date: 2016-05-13