Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.

Not Applicable

• Conditions: glaucoma

• Registration Number: JPRN-UMIN000030742
• Lead Sponsor: Yotsuya Shirato Ophthalmology Clinic

Brief Summary

The treated eyes showed significant reduction in IOP at 1 and 3 months. In contrast, contralateral untreated eyes did not show IOP reduction. IOP reduction of - 20% and - 30% was achieved in 30% and 10% treated eyes, respectively. There were significant differences in IOP between the treated and contralateral untreated eyes at 1 and 3 months. Two patients experienced local adverse events but soon recovered by discontinuing ripasudil. Ripasudil could be used to enhance the outcome of FP monotherapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-18
• Study Completion: 2020-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with a contraindicated condition to use the study drug 2. Patients who are breastfeeding, pregnant, or parturient 3. Patients whose best-corrected visual acuity is less than 0.5 4. Patients whose spherical equivalent is less than -0.9D or +0.9 or higher 5. Patients in whom the difference of spherical equivalent between both eyes is 3D or higher 6. Patients whose intraocular pressure can not be correctly measured by Goldmann applanation tonometer 7. Patients whose mydriasis is insufficient and in whom the observation of the optic nerve head is impossible 8. Patients with history of invasive eye surgery or laser treatment, except cataract surgery within 6 months 9. Patients with eye trauma 10. Patients with complication of retina disease which affect visual field 11. Patients with optic nerve disease or intracranial disease which affect visual field 12. Patients with other conditions that the investigator/researcher thinks inappropriate for the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of intraocular pressure between at baseline (week 0) and at follow-up period (week 12)