Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension
| Autor: | Hisashi Kawata, Makoto Aihara, Noriko Odani-Kawabata, Fenghe Lu, Akihiro Iwata, Naveed K Shams |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
0303 health sciences
Intraocular pressure medicine.medical_specialty genetic structures Open angle glaucoma business.industry Glaucoma Ocular hypertension medicine.disease eye diseases Confidence interval 03 medical and health sciences Ophthalmology chemistry.chemical_compound 0302 clinical medicine chemistry 030221 ophthalmology & optometry Clinical endpoint Medicine sense organs Latanoprost business Adverse effect 030304 developmental biology |
| Zdroj: | American Journal of Ophthalmology. 220:53-63 |
| ISSN: | 0002-9394 |
| Popis: | Purpose To evaluate the efficacy and safety of omidenepag isopropyl (OMDI), a selective, non-prostaglandin, prostanoid EP2 receptor agonist, in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Design Phase III, randomized, investigator-masked, active-controlled, parallel-group, noninferiority study ( ClinicalTrials.gov NCT02623738 ). Methods After a washout period of 1-4 weeks, eligible patients were randomized (1:1) to OMDI 0.002% or latanoprost 0.005% once daily for 4 weeks. Intraocular pressure (IOP) was measured at 9:00 AM, 1:00 PM, and 5:00 PM at weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at week 4. The noninferiority margin for OMDI versus latanoprost was 1.5 mm Hg. Adverse events (AEs) were recorded. Results Of the 190 patients randomized, 189 had at least 1 post-baseline IOP measurement. At baseline, patients who received OMDI or latanoprost had a mean ± SD diurnal IOP of 23.78 ± 1.73 mm Hg and 23.40 ± 1.51 mm Hg, respectively. At week 4, least-squares mean ± SE reduction in IOP from baseline with OMDI (−5.93 ± 0.23 mm Hg) was noninferior to that of latanoprost (−6.56 ± 0.22 mm Hg; 95% confidence interval between groups: 0.01-1.26). The most frequently reported treatment-related ocular AEs (OMDI vs latanoprost) were conjunctival hyperemia (23/94 patients [24.5%] vs 10/96 patients [10.4%]), corneal thickening (11/94 patients [11.7%] vs 1/96 patients [1.0%]), and punctate keratitis (0/94 patients vs 5/96 patients [5.2%]). No serious AEs were observed in either group, and there were no discontinuations related to the study drug. Conclusions OMDI 0.002% was noninferior to latanoprost 0.005% in reducing IOP in patients with OHT or POAG and was well tolerated. |
| Databáze: | OpenAIRE |
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