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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

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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


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.


14 clinical sites in Canada and Australia


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.


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).


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

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