Investigation of Lubricant Eyedrop Compared With Carboxymethylcellulose 0.5% in Patients After LASIK Surgery: Randomized 90-Day Trial

Friday, April 17, 2015
KIOSKS (San Diego Convention Center)
Avi Wallerstein, MD, FRCSC
W. Bruce Jackson, MD, FRCSC
Jeffrey Chambers, MD
Amir Moezzi, MSc, BOptom
James J. Wiens, MD, FRCSC
Hugh Lin, MD, MBA

Purpose
Postoperative signs and symptoms of dryness are common following laser in-situ keratomileusis (LASIK) surgery.  This study compared the safety and efficacy of an investigational unit dose lubricant eye drop containing both Carboxymethylcellulose and Hyaluronic Acid (CMC-HA) with 0.5% Carboxymethylcellulose alone (CMC) in subjects following LASIK for myopia or hyperopia.

Methods
This prospective, multicenter, double-masked, randomized, 2-arm, parallel group study enrolled patients following successful LASIK surgery for myopia or hyperopia.  148 patients were recruited at 14 sites in Canada and Australia.  Patients were randomized 1:1 to either CMC-HA or CMC (Refresh Plus, Allergan) for 3 months following LASIK surgery.  Patients were administered the Ocular Surface Disease Index (OSDI), acceptability surveys, and were evaluated for corneal staining, tear break-up time (TBUT), and the Schirmer test at screening (prior to surgery) and at 1 week, and 1, 2, and 3 months post-op.

Results
Dry eye signs and symptoms generally peaked at 1 week post-operatively and improved thereafter.  Mean OSDI scores 3 months following LASIK were similar between treatments (p=0.775) and had returned to the normal range.  Notably, uncorrected visual acuity mean change from baseline for CMC-HA was better at all visits compared to CMC and the difference between treatments was significant at 1 month (p=0.013).  Corneal staining, Schirmer test, TBUT, and survey results were comparable.  Safety assessment was acceptable in both groups but fewer subjects reported at least one ocular adverse event in the CMC-HA group (6 subjects) than for CMC (12 subjects).

Conclusion
CMC-HA drops were as effective in treating post-surgical dryness as CMC alone in patients completing LASIK, with an incremental benefit to vision.  While both eye drops were safe and well tolerated with no treatment-related serious adverse events, the overall safety profile favored the new CMC-HA eye drop.