Quantitative evaluation of ROCK inhibitor and a2 adrenoceptor agonist inducing conjunctival hyperemia study (ROCKa-hy study)

未提供0 个研究点目标入组 50 人开始时间: 2024年10月3日最近更新: 2025年4月8日

适应症

试验速览

暂无简介。

•Patients with open-angle glaucoma (broad definition) who are using ripasudil ophthalmic solution for glaucoma eye drop treatment and need intensified treatment
•Selection Criteria
•Patients 18 years of age or older with open-angle glaucoma (broad definition) who require additional glaucoma treatment due to inadequate IOP reduction with prior glaucoma eye drops.
•Patients who have received ripasudil ophthalmic solution as prior glaucoma eye drops for at least 8 weeks on the date of initial hyperemia assessment (Visit 2)
•Patients who have given written consent to participate in the study

•Patients who have received ophthalmic solutions containing brimonidine tartrate within 4 weeks of the first hyperemia evaluation date (Visit 2)
•Patients with a history of hypersensitivity to ripasudil hydrochloride hydrate, brimonidine tartrate, anhydrous sodium dihydrogen phosphate, sodium chloride, glycerin, sodium hydroxide, or concentrated benzalkonium chloride solution 50
•Pregnant, parturient, or lactating women
•Patients with secondary glaucoma (excluding exfoliation glaucoma) and patients with angle closure glaucoma
•Patients who have difficulty measuring intraocular pressure with iCare
•Patients with concomitant ocular trauma
•Patients with anterior segment inflammatory disease with hyperemia
•Patients who are unable to have anterior segment photographs taken.
•Patients with a history of intraocular surgery within 6 months of the first hyperemia evaluation (Visit 2)
•Contact lens wearers
•11.Patients who are deemed to be inappropriate for this study by the investigator .

Difference in pixel coverage of conjunctival vessels

时间窗: 60 minutes after eye drop

Pixel coverage of conjunctival vessels before and after administration

Difference in pixel coverage of conjunctival blood vessels(after 15 minutes and 120 minutes of eye drop)
Questionnaire on hyperemia(0 minutes, 15 minutes, 60 minutes, 120 minutes after eye drop)
Questionnaire on comfort of use
Intraocular pressure(0 min and 120 min after eye drop)
Safety

发起方

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