Comparison of new multi-ingredient lubricant eye drop containing hyaluronic acid vs carboxymethylcellulose 0.5% for ocular dryness following LASIK surgery: a multicenter, randomized 90 day study

Session Details

Session Title: LASIK I

Session Date/Time: Sunday 06/09/2015 | 08:00-10:00

Paper Time: 09:21

Venue: Room 11

First Author: : A.Wallerstein CANADA

Co Author(s): :    W. Jackson   J. Chambers   A. Moezzi   J. Wiens   H. Lin        

Abstract Details

Purpose:

Ocular dryness is common following laser in-situ keratomileusis (LASIK) surgery. The efficacy and safety of an investigational unit dose lubricant eye drop containing carboxymethylcellulose 0.5% and hyaluronic acid 0.1% (CMC-HA) and carboxymethylcellulose 0.5% alone (CMC, REFRESH PLUS, Allergan) were compared in the management of postoperative signs and symptoms of dryness following LASIK surgery for myopia or hyperopia.

Setting:

14 clinical sites in Canada and Australia

Methods:

This double-masked study recruited patients with no more than mild pre-surgical dry eye who underwent successful LASIK surgery. Patients were randomized 1:1 to either CMC-HA or CMC for 90 days post-LASIK. Dosing was every 1-2 hours for the immediate 10 post-surgery days, followed by an investigator assigned regimen (minimum: 1-2 times/day, maximum: ≥ every 2 hrs). Assessments included the Ocular Surface Disease Index (OSDI; primary efficacy variable), corneal staining, tear break-up time (TBUT), the Schirmer's test, acceptability/tolerability surveys, and visual acuity, at screening and days 2, 10, 30, 60 and 90 post-surgery. Safety analyses included all enrolled patients.

Results:

Of 148 enrolled patients, 75 received CMC-HA and 73 received CMC (intent-to-treat population); 126 patients were in the per-protocol population. As expected, dry eye signs/symptoms peaked at 10 days. By day 90, mean OSDI scores for both groups returned to normal; there were no differences between drop treatment groups (p=0.775). Corneal staining, Schirmer's test, TBUT, and survey results were comparable. Mean change in uncorrected visual acuity from day 2 post-surgery was better in patients receiving CMC-HA versus CMC (p=0.013, day 30). Both treatments were well tolerated; fewer patients receiving CMC-HA reported ≥ one ocular adverse events (6 vs 12).

Conclusions:

CMC-HA eye drops were as effective as CMC drops in treating post-LASIK ocular dryness, with an incremental benefit to uncorrected vision. While both drops were safe and well tolerated, with no treatment-related serious adverse events, the overall safety profile was more favourable in patients receiving CMC-HA. These results support the use of CMC-HA eye drops to reduce the signs and symptoms of ocular dryness in post-LASIK patients.

Financial Interest:

One of the authors is employed by a for-profit company with an interest in the subject of the presentation, One of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented