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

UMIN ID: UMIN000030742

Registered date:18/01/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: glaucoma
• Date of first enrollment: 2019/01/18
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Comparison of intraocular pressure between at baseline (week 0) and at follow-up period (week 12)
• Secondary Outcome: 1. Change of intraocular pressure in the study eye at the same time of week 4 from baseline (week 0) 2. Achievement rate of -20% or -30% intraocular pressure reduction in the study eye at the same time of week 12 from baseline (week 0) 3. Difference of intraocular pressure reduction between the study eye and non-treated eye at the same time of week 12 from baseline (week 0) 4. Difference of intraocular pressure reduction between the study eye and non-treated eye at the same time of week 4 from baseline (week 0) 5. Change of indexes listed below at the study eye at the same time of week 12 from baseline (week 0) 6. Change of indexes listed below at the study eye at the same time of week 4 from baseline (week 0) 7. Differences of indexes listed below between the study eye and non-treated eye at the same time of week 12 from baseline (week 0) 8. Differences of indexes listed below between the study eye and non-treated eye at the same time of week 4 from baseline (week 0) 9. Change of difference between the study eye and non-treated eye from baseline to week 12 10. Frequency of adverse events and adverse reactions <indexes> intraocular pressure measured by Goldmann applanation tonometer visual acuity gonioscopy test slit lamp microscope test fundus test history of prostaglandin-related drug treatment

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Yotsuya Shirato Ophthalmology Clinic
• Source(s) of Monetary Support: Kowa Company, Ltd.