glaucoma
Conditions
Interventions
None listed
Sponsors
Yotsuya Shirato Ophthalmology Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. One prostaglandin-related drug did not provide sufficient reduction in intraocular pressure, and after December 2017, at the discretion of the attending physician, additional glaucoma treatment with ripasudil hydrochloride was required or will be performed Glaucoma patients in the future. 2. Intraocular pressure of both eyes are 15mmHg or lower at their consent and week 0, and difference of intraocular pressure at their consent and at the latest consultation before the consent is 2mmHg or lower. 3. Male and female patients aged 20 years or older and younger than 75 years when giving their consent. 4. Patients who can give their consent in a written form
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of intraocular pressure between at baseline (week 0) and at follow-up period (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed