Clinical Ophthalmology (May 2018)
Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose
Abstract
Avi Wallerstein,1,2 W Bruce Jackson,3 Jeffrey Chambers,4 Amir M Moezzi,5 Hugh Lin,6 Peter A Simmons6 1Department of Ophthalmology, McGill University, Montreal, QC, Canada; 2LASIK MD, Montreal, QC, Canada; 3University of Ottawa Eye Institute of the Ottawa Hospital, Ottawa, ON, Canada; 4Kelowna Eye Care Center, Kelowna, BC, Canada; 5Centre for Ocular Research & Education (CORE, formerly Centre for Contact Lens Research), School of Optometry & Vision Science, University of Waterloo, Waterloo, ON, Canada; 6Allergan Clinical Research, Allergan plc, Irvine, CA, USA Purpose: To compare the efficacy and safety of a preservative-free, multi-ingredient formulation of carboxymethylcellulose 0.5%, hyaluronic acid 0.1%, and organic osmolytes (CMC-HA), to preservative-free carboxymethylcellulose 0.5% (CMC) in the management of postoperative signs and symptoms of dry eye following laser-assisted in situ keratomileusis (LASIK). Methods: This was a double-masked, randomized, parallel-group study conducted in 14 clinical centers in Canada and Australia. Subjects with no more than mild dry eye instilled CMC-HA or CMC for 90 days post-LASIK. Ocular Surface Disease Index© (OSDI; primary efficacy measure), corneal staining, tear break-up time (TBUT), Schirmer’s test, acceptability/tolerability surveys, and visual acuity were assessed at screening and days 2, 10, 30, 60, and 90 post-surgery. Safety analyses included all enrolled. Results: A total of 148 subjects (CMC-HA, n=75; CMC, n=73) were enrolled and assigned to receive treatment, and 126 subjects completed the study without any protocol violations. Post-LASIK, dry eye signs/symptoms peaked at 10 days. OSDI scores for both groups returned to normal with no differences between treatment groups at day 90 (P=0.775). Corneal staining, Schirmer’s test, TBUT, and survey results were comparable. Higher mean improvements in uncorrected visual acuity were observed in the CMC-HA group at all study visits, reaching statistical significance at day 30 (P=0.013). Both treatments were well tolerated. Conclusion: CMC-HA-containing artificial tears relieved post-LASIK ocular dryness as well as CMC alone, and demonstrated incremental benefit in uncorrected vision, with a favorable safety profile. Results support use of CMC-HA eye drops to reduce signs and symptoms of ocular dryness post-LASIK. Keywords: LASIK, dry eye, artificial tears, carboxymethylcellulose, hyaluronic acid, ocular surface disease
