Reduction in Analgesic Use and Postoperative Ocular Pain With New Irrigating Solution During Cataract and IOL Replacement Procedures
Purpose
Post-hoc integrated analyses of subject-reported early postoperative pain and documented analgesic use following cataract and intraocular lens replacement (ILR) procedures – pooled data from three prospective, randomized controlled studies of OMS302 (Omidria [phenylephrine and ketorolac injection] 1%/0.3%).
Methods
Data from 3 prospective, controlled, randomized clinical studies of OMS302 in subjects undergoing cataract extraction/replacement or refractive lens exchange surgery were included in a pooled post-hoc and integrated analysis of 1) early postoperative ocular pain and 2) analgesic use on the day of the procedure. Early postoperative ocular pain was assessed by each subject using a visual analog scale (VAS) at the following time points: 2, 4, 6, 8, and 10–12 hours after surgery. Analgesic use on day of surgery was recorded. A total of 919 subjects (461 placebo and 458 OMS302) were included.
Results
The mean area-under-the-curve (AUC) difference (standard error) in VAS scores between subjects treated with OMS302 vs subjects treated with placebo was -4.94 mm (0.77) (95% CI: -6.44 to -3.44, p<0.001). Significantly more OMS302 subjects were pain free (VAS=0) at all postoperative evaluations (26.0% vs 17.2 %, p=0.0012) and significantly less OMS302 subjects had moderate to severe pain (VAS≥40) at any time point (7.2% vs 14.4%, p=0.0005; respectively). Additionally, analgesic use on day of surgery was significantly lower for OMS302 subjects compared to placebo subjects (27.5% vs 37.1 %, p=0.0019, respectively).
Conclusion
OMS302 was associated with significantly less postoperative ocular pain and pain medication use on day of cataract surgery or intraocular lens replacement. Use of OMS302 in these settings may improve overall patient satisfaction with these procedures.