Posters

Clinical evaluation of a new enhanced viscosity eye drop for moderate-to-severe dry eye disease: a multicenter double-masked randomised 30 day study

Poster Details

First Author: R.Gil Cazorla UK

Co Author(s):    C. Lievens   G. Berdy   D. Douglass   S. Montaquila   L. Hugh   P. Simmons   C. Carlisle-Wilcox   M. Changela

Abstract Details

Purpose:

An investigational lubricant eye drop with enhanced viscosity containing carboxymethylcellulose 1.0% / glycerin 0.9% (OGD, Optive Gel Drops, Allergan) was compared to carboxymethylcellulose 1% alone (CMC, REFRESH LIQUIGEL, Allergan) in a randomized, controlled clinical trial.

Setting:

Missouri-USA: Comprehensive Eye Care, Ltd. Moyes Eye Center, PC Ophthalmology Associates Tennesee-USA: Eye Center at Southern College of Optometry Primary Eyecare Group, PC California-USA: Eric M. White, OD, Inc. North Bay Eye Associates Other-USA: Eye Center Northeast (ME) David W. Ferris & Associates, Inc. (RI) Rochester Ophthalmological Group, PC (NY)

Methods:

This double-masked study recruited patients with moderate to severe dry eye at 10 US centers. After a seven-day run-in with REFRESH TEARS, patients were randomized to use either OGD or CMC as needed, but at least 2X daily for 30 days. Patients were stratified by Ocular Surface Disease Index (OSDI) score (moderate = 23-32; severe = 33-65). Assessments included the OSDI (primary efficacy variable), corneal and conjunctival staining, tear break-up time (TBUT), symptom surveys, and safety variables. Study visits were days 1 (baseline/randomization), 7, and 30.

Results:

188 patients (94 OGD, 94 CMC) were enrolled. The severe subgroup had 67 OGD and 65 CMC patients. OSDI scores progressively improved and were similar at day 30 between treatment groups. At day 7, only the CMC-GLY group demonstrated significant improvements from baseline in OSDI score (all patients p<0.001, severe p<0.001), corneal staining (p=0.004), and TBUT (p<0.001). Between group dose frequency for OGD was lower at Day 7 (p=0.031). Other efficacy results were similar between groups. The most commonly-reported adverse event in both groups was blurred vision.

Conclusions:

Overall, OGD was as effective as CMC eye drops. OGD demonstrated improvements at an earlier stage (Day 7). Both drops were safe and well-tolerated, with no treatment-related serious adverse events. These results support the use of OGD as an effective treatment to reduce the symptoms and signs of dry eye disease.

Financial Disclosure:

is employed by a competing company, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented