Two Phase 3 Clinical Trials of Preservative-Free/Bisulfite-Free Phenylephrine-Ketoralac Agent Added to Irrigation Fluid During IOL Replacement Surgery

Walters, Thomas

Two Phase 3 Clinical Trials of Preservative-Free/Bisulfite-Free Phenylephrine-Ketoralac Agent Added to Irrigation Fluid During IOL Replacement Surgery

Sunday, April 27, 2014: 3:48 PM

Room 152 (Boston Convention and Exhibition Center)

Thomas R. Walters, MD, Texan Eye, Austin, TX, USA

Mitchell A. Jackson, MD, Jacksoneye, SC, Lake Villa, IL, USA

Alan S. Crandall, MD, John A. Moran Eye Center, Salt Lake City, Utah, USA

James C. Loden, MD, Loden Vision Centers, Goodlettsville, TN, USA

Narrative Responses:

Purpose
Purpose: These studies evaluated the efficacy and safety of OMS302 on pupil size and acute postoperative pain associated with cataract and clear lens procedures (collectively, intraocular lens replacement [ILR]). OMS302 is an investigational drug containing phenylephrine (PE) and ketorolac (KE) administered intracamerally in irrigation fluid.

Methods
Methods: These studies evaluated the effects of OMS302 on maintenance of mydriasis and prevention of miosis intraoperatively, and reduction of postoperative pain. Both were randomized, double-masked, and placebo-controlled. All patients received preop mydriatics and anesthetics. Intra-operative mydriasis and miosis were evaluated by review of all surgical procedures, each video-recorded and read by a central reader. Pupil diameter was measured every minute intraoperatively. Pain was assessed every 2 hours postoperatively for 12 hours. Safety was evaluated by adverse events, vital signs, and ophthalmological examination for 14 days postop. The analysis population was intent-to-treat.

Results
Results: Pupil diameter was maintained in the OMS302 group. Placebo patients experienced steady pupil constriction (p < 0.0001). OMS302 was also superior in categorical analyses.

Pupil diameter < 6 mm during surgery: Placebo(N=405) 42%; OMS302(N=403) 10%; p-value <0.0001. Pupil constriction >= 2.5 mm during surgery: Placebo(N=405) 27%; OMS302(N=403) 2%; p-value<0.0001.

Mean reported acute postoperative pain was greater in placebo patients than in OMS302 patients (p<0.0001).

Pain-free patients: Placebo(N=405) 17%; OMS302(N=403) 26%; p-value 0.0027. Patients with moderate-to-severe pain: Placebo(N=405) 14%; OMS302(N=403) 7%; p-value 0.0014.

The most common adverse events (AEs) were more frequently reported on placebo, and were eye pain, eye inflammation and headache.

Conclusion
Conclusions: In these studies, OMS302 maintained intraoperative mydriasis, prevented intraoperative miosis, and reduced acute postoperative pain compared to placebo in the setting of all patients receiving standard preoperative mydriatic and anesthetic agents. OMS302 was well tolerated.