Decreased analgesic use and postoperative ocular pain following OMS302 treatment during cataract and intraocular lens replacement procedures

Session Details

Session Title: Presented Poster Session: Cataract Surgery Complications and Management IV

Session Date/Time: Sunday 06/09/2015 | 15:00-16:30

Paper Time: 15:10

Venue: Poster Village: Pod 1

First Author: : A.Crandall USA

Co Author(s): :    E. Holland   D. Schaaf   K. Tjia        

Abstract Details

Purpose:

OMS302 is an investigational drug containing phenylephrine 1% and ketorolac 0.3% for use during cataract surgery to maintain mydriasis, prevent intraoperative miosis, and reduce early postoperative ocular pain. A post-hoc, pooled analysis of early postoperative pain and analgesic use was performed to determine effect of OMS302 treatment during surgical procedures.

Setting:

Three clinical studies (one Phase 2, two Phase 3) of OMS302 in subjects undergoing cataract surgery or refractive lens exchange. Investigational sites were located in the United States and European Union. A total of 919 subjects (461 placebo and 458 OMS302) participated in these studies.

Methods:

A post-hoc, pooled analysis of 1) early postoperative ocular pain and 2) analgesic use on the day of surgical procedure was performed on integrated data from three prospective, controlled, randomized clinical studies of OMS302 in subjects undergoing cataract surgery or refractive lens exchange. Subject-reported postoperative ocular pain was assessed at 2, 4, 6, 8, and 10–12 hours using a visual analog scale (VAS) and analgesic use on day of surgery was recorded. VAS scores were analyzed using mean area-under-the-curve (AUC) differences between placebo and OMS302 treatment groups.

Results:

Subjects treated with OMS302 experienced significantly less early postoperative pain compared to subjects treated with placebo (mean AUC difference [standard error] of 4.94 mm [0.77] [95% CI: -6.44 to -3.44, p<0.001]). OMS302 treatment was also associated with significantly more subjects who were pain free (VAS=0) at all postoperative evaluations (26.0% OMS302 vs 17.2% placebo, p=0.0012) and experienced significantly less moderate-to-severe pain (VAS≥40) at any early postoperative time point (7.2% OMS302 vs 14.4% placebo, p=0.0005). Analgesic use on day of surgery was also significantly lower among subjects treated with OMS302 compared to placebo subjects (27.5% vs 37.1%, p=0.0019).

Conclusions:

Subjects treated with OMS302 during cataract surgery or refractive lens exchange experienced significantly less postoperative ocular pain and used significantly less pain medication on the procedure day compared to subjects treated with placebo. These results suggest that OMS302 may improve patient satisfaction associated with cataract surgery and other lens replacement procedures.

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 competing company, One of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented