Efficacy and Safety Comparison of Omidenepag Isopropyl and Latanoprost: A Phase-4 Clinical Trial

Purpose: This study aimed to compare the intraocular pressure (IOP)-lowering efficacy, incidence of adverse effects, tolerability, and patient satisfaction of omidenepag isopropyl 0.002% and latanoprost 0.005% in a real-world clinical setting.Methods: A total of 100 patients with glaucoma were randomized to receive either omidenepag isopropyl or latanoprost. Changes in IOP, the incidence of adverse effects, and patient satisfaction were assessed at 1 and 6 months after treatment initiation.Results: Ninety patients were included in the final analysis. At 1 month, the reduction in IOP was significantly greater in the latanoprost group (−1.98 ± 2.09 mmHg) than in the omidenepag isopropyl group (−1.07 ± 1.86 mmHg; p = 0.034). However, no significant difference between groups was observed at 6 months (−2.43 ± 2.68 mmHg vs. −1.73 ± 2.34 mmHg; p = 0.189). The incidence of adverse effects did not differ significantly between the two groups with the exception of transient blurred vision at 1 minute after instillation at both 1 and 6 months, and foreign body sensation. Latanoprost was associated with significantly better instillation comfort at both time points (p = 0.005), whereas overall patient satisfaction scores were not significantly different (p = 0.483).Conclusions: Latanoprost demonstrated superior short-term (1-month) IOP reduction and slightly better instillation comfort at both 1 and 6 months, while long-term (6-month) IOP-lowering efficacy was comparable between the two agents. These findings provide practical evidence for informing drug selection in routine clinical practice.