Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management.

Purpose: To assess the safety of phenylephrine and ketorolac (PE/K) 1.0%/0.3% compared with phenylephrine (PE) 1.0% in children aged 0 to 3 years undergoing cataract surgery. The effect of PE/K to PE on intraoperative pupil diameter and postoperative pain were also compared.

Setting: Multicenter study in the United States.

Design: Randomized double-masked phase 3 clinical trial.

Methods: This study was powered to assess safety only. Depending on randomization, 4 mL of PE/K 1.0%/0.3% or PE 1.0% was injected into the surgical irrigation solution. Safety endpoints were assessed up to 90 days postoperatively. From surgical videos, a masked central reader measured the change in pupil diameter from immediately prior to incision to wound closure. Postoperative pain was measured using Alder Hey Triage Pain Score at 3 hours, 6 hours, 9 hours, and 24 hours following wound closure and recorded by parent/caregiver.

Results: Seventy-two patients received masked intervention. There were no notable changes in vital signs or ophthalmological complications in either group. Mean change in pupil diameter was similar between PE/K 1.0%/0.3% and PE 1.0% (mean difference in area under the curve -0.071; P = .599). Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P = .029 and 0.021, respectively).

Conclusions: PE/K 1.0%/0.3% was safe for use in children and maintained mydriasis during cataract surgery. Postoperative pain levels were lower in the PE/K 1.0%/0.3% group.