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Two phase 3 clinical trials of preservative-free/bisulfite-free OMS302 added to irrigation fluid during intraocular lens replacement surgery

Poster Details

First Author: S.Whitaker USA

Co Author(s):    G. Demopulos              

Abstract Details



Purpose:

The purpose of these studies was to evaluate the effect of OMS302 on intraoperative pupil size and postoperative pain associated with cataract and clear lens procedures (collectively, intraocular lens replacement [ILR]). Three measures of pupil diameter and three measures of postoperative pain were prospectively defined and analyzed. OMS302, an investigational drug formulated to contain phenylephrine (PE) and ketorolac (KE), is administered intracamerally in irrigation fluid.

Setting:

Two multicentre Phase 3 clinical trials conducted in academic and community practice settings

Methods:

Data from two Phase 3 (ILR-003 and ILR-004) clinical trials are included in this analysis. These trials evaluated the effects of OMS302 on (1) maintenance of mydriasis and prevention of miosis intraoperatively and (2) reduction of acute postoperative ocular pain. Each clinical trial was randomized, double-masked, and placebo-controlled. Subjects undergoing unilateral ILR with monofocal, toric, multifocal, or accommodating lenses were eligible. Subjects having conditions that could complicate the analyses (e.g., active inflammation or prior iris trauma) were excluded. Preoperatively, all subjects received standardized topical PE, tropicamide, and an anesthetic agent (lidocaine or tetracaine). Study drug was delivered only intraoperatively in the irrigation solution. Intraoperative pupil diameter was captured on video and measured using ImageJ software by a single, masked, central reader. Pupil diameter was measured every minute intraoperatively. Paracetamol was provided to all subjects for use as needed following surgery. Postoperative pain was measured by a Visual Analog Scale (VAS) completed by subjects at 2, 4, 6, 8, and 10-12 hours postoperatively. All analyses are intent-to-treat. Safety and tolerability were evaluated using adverse-event reporting, vital signs, and ocular examinations postoperatively for 14 to 90 days.

Results:

Eight hundred and eight subjects received study treatment and 801 completed the studies (3 placebo and 4 OMS302 subjects discontinued). Pupil diameter was maintained in the OMS302 group while placebo subjects experienced steady pupil constriction during the procedures (p<0.0001). OMS302 was superior to placebo in prevention of intraoperative miosis defined as an absolute pupil diameter of less than 6 mm during surgery or intraoperative pupil constriction ≥2.5 mm. Forty-two percent of placebo-treated subjects experienced a pupil diameter <6 mm compared to 10% of OMS302-treated subjects (p<0.0001). Twenty-seven percent of placebo-treated subjects experienced pupil constriction ≤2.5 mm compared to 2% on OMS302 (p<0.0001). OMS302-treated subjects reported less pain than placebo-treated subjects. The difference in mean pain scores was -4.94 (p<0.001). Fourteen percent of placebo-treated subjects reported moderate-to-severe pain (VAS pain score of ≥40) compared to 7% of OMS302-treated subjects (p=0.001). By comparison, 26% of OMS302-treated subjects reported no postoperative pain compared to 17% of placebo-treated subjects. While lower pain scores were reported in the OMS302-treated group, more postoperative pain medication was used by placebo-treated patients on the day of surgery. The most common adverse events (≥5% in either treatment group) were eye pain, eye inflammation, headache, and ocular discomfort.

Conclusions:

In these Phase 3 clinical trials in which all subjects received standard preoperative topical mydriatic and anesthetic agents, OMS302 maintained intraoperative mydriasis and prevented intraoperative miosis compared to placebo. The definitions of miosis were chosen because a pupil diameter of less than 6 mm is associated with a substantially increased risk of complications and pupil constriction of 2.5 mm represented a decrease of approximately 50% in total pupillary area. OMS302 reduced postoperative pain generally and also decreased the incidence of moderate-to-severe pain. In addition, the proportion of pain-free subjects was greater in the OMS302-treated group. OMS302 was well tolerated. FINANCIAL INTEREST: One of more of the authors... has significant investment interest in a company producing, developing or supplying product or procedure presented, One of more of the authors... is employed by a forNONEprofit company with an interest in the subject of the presentation

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