Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose

Abstract

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; artificial tears; carboxymethylcellulose; dry eye; hyaluronic acid; ocular surface disease.

Conflict of interest statement

Disclosure Avi Wallerstein received research funding for the conduct of the study. W Bruce Jackson received research funding for the conduct of the study and has served as a consultant to Allergan plc. Amir Moezzi received research funding from Allergan plc for the conduct of the study. Peter A Simmons was an employee of Allergan plc, Irvine, CA, USA at the time the study was conducted and has patents licensed to Allergan plc relevant to the reported study. Hugh Lin was an employee of Allergan plc, Irvine, CA, USA at the time the study was conducted and is currently a medical director at Genentech, a company that does operate in the ophthalmology space. Jeffrey Chambers reports no conflicts of interest in this work.

Figures

Figure 1

Mean overall Ocular Surface Disease Index© (OSDI) scores at study visits. Note: Error bars indicate standard error of the mean (per-protocol population). Abbreviations: CMC, carboxymethylcellulose 0.5%; CMC-HA, carboxymethylcellulose 0.5%, hyaluronic acid 0.1%.

Figure 2

Change in mean uncorrected visual acuity in the worse eye post-LASIK surgery. Notes: Error bars indicate standard error of the mean (per-protocol population). *P=0.013 for between group difference in the change from day 2 in total number of letters read correctly (ANOVA model with fixed effects of treatment and the stratification factor using the type III sum of squares). Abbreviations: CMC, carboxymethylcellulose 0.5%; CMC-HA, carboxymethylcellulose 0.5%, hyaluronic acid 0.1%; LASIK, laser-assisted in situ keratomileusis.

Figure 3

Mean (A) corneal staining, (B) Schirmer’s test score, and (C) tear break-up time at study visits. Notes: Error bars indicate standard error of the mean (A), per-protocol population; (B and C), intent-to-treat population. *P<0.01; **P<0.05 for within-group comparison with baseline (paired t-test). Abbreviations: CMC, carboxymethylcellulose 0.5%; CMC-HA, carboxymethylcellulose 0.5%, hyaluronic acid 0.1%.