Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension
| Autor: | Kiyotaka Hori, Naomi Otsuka, Kenji Takazawa, Kenji Nakamoto, Ayaka Takeda, Yusuke Nishio, Naruhiro Ishida, Daisuke Shii, Shio Sugimoto, Naka Shiratori |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Intraocular pressure Visual acuity Supine position genetic structures business.industry omidenepag isopropyl Ocular hypertension Glaucoma Clinical Ophthalmology medicine.disease eye diseases Ophthalmology Blood pressure prostanoid EP2 agonist Heart rate medicine 24-hour IOP control sense organs medicine.symptom Adverse effect business Original Research |
| Zdroj: | Clinical Ophthalmology (Auckland, N.Z.) |
| ISSN: | 1177-5483 |
| Popis: | Naka Shiratori,1,2 Yusuke Nishio,1,2 Ayaka Takeda,1,2 Shio Sugimoto,1,2 Kenji Takazawa,2 Naomi Otsuka,3 Naruhiro Ishida,3 Daisuke Shii,3 Kiyotaka Hori,3 Kenji Nakamoto1 1Department of Ophthalmology, Nippon Medical School, Tokyo, Japan; 2Shinanozaka Clinic, Tokyo, Japan; 3Japan Medical Affairs Group, Santen Pharmaceutical Co. Ltd., Osaka, JapanCorrespondence: Naka ShiratoriDepartment of Ophthalmology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, JapanTel +81-3-3822-2131Fax +81-3-5685-0988Email shiratori@nms.ac.jpPurpose: To clarify the intraocular pressure (IOP)-lowering effect of a selective prostanoid EP2 receptor agonist, omidenepag isopropyl (OMDI) during a 24-hour period.Patients and Methods: Subjects aged ⥠20 years and with diagnosed, untreated primary open-angle glaucoma or ocular hypertension were enrolled. IOP measurements were performed every 4 hours over a 24-hour period using a Goldmann applanation tonometer (GAT) and Icare PRO tonometer (PRO). The baseline 24-hour IOP was measured in untreated subjects. After the baseline measurements, participants were given OMDI 1 drop once daily at night for 4 weeks. At week 4, the IOP measurement was repeated under the same conditions. Diurnal (9 am, 1 pm, 5 pm) and nocturnal (9 pm, 1 am, 5 am) IOP measurements were compared between baseline and treatment with OMDI. Safety measures included adverse events, slit-lamp biomicroscopy, visual acuity, heart rate and blood pressure.Results: Of 27 participants enrolled, 25 patients (20 males and 5 females, average age 52.2 ± 8.5 years) completed the study. In the sitting position, the baseline diurnal and nocturnal mean IOPs (GAT) were 19.1 ± 2.1 mmHg and 18.2 ± 2.6 mmHg, respectively, the diurnal and nocturnal mean IOP reduction from baseline were â 2.8 ± 2.6 mmHg (p < 0.0001) and â 3.3 ± 2.9 mmHg (p < 0.0001), respectively, mean 24-hour IOP (GAT) was significantly lower with the OMDI treatment (â 3.1 ± 2.5 mmHg, p < 0.0001). In the supine position, the baseline nocturnal mean IOP (PRO) was 17.99 ± 2.22 mmHg, and the nocturnal mean IOP reduction from baseline was â 1.78 ± 2.37 mmHg (p = 0.0009) after 4 weeks of the treatment. Nine adverse events were observed in 8 patients including mild conjunctival hyperemia (n = 8) and mild iritis (n=1). There were no significant effects on systemic safety.Conclusion: Once daily OMDI treatment was able to produce stable 24-hour IOP reduction.Keywords: omidenepag isopropyl, prostanoid EP2 agonist, 24-hour IOP control |
| Databáze: | OpenAIRE |
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