open-angle glaucoma glaucoma
Conditions
Interventions
Obtain written consent from potential subjects (Visit 1). Patients who are confirmed eligible will receive one drop of ripasudil ophthalmic solution once, and anterior segment photography will be perf
eye drop
Sponsors
Kazuyuki Hirooka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with open-angle glaucoma (broad definition) who are using ripasudil ophthalmic solution for glaucoma eye drop treatment and need intensified treatment Selection Criteria 1. 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. 2. 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) 3. Patients who have given written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients who have received ophthalmic solutions containing brimonidine tartrate within 4 weeks of the first hyperemia evaluation date (Visit 2) 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 3. Pregnant, parturient, or lactating women 4. Patients with secondary glaucoma (excluding exfoliation glaucoma) and patients with angle closure glaucoma 5. Patients who have difficulty measuring intraocular pressure with iCare 6. Patients with concomitant ocular trauma 7. Patients with anterior segment inflammatory disease with hyperemia 8. Patients who are unable to have anterior segment photographs taken. 9. Patients with a history of intraocular surgery within 6 months of the first hyperemia evaluation (Visit 2) 10. Contact lens wearers 11.Patients who are deemed to be inappropriate for this study by the investigator .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in pixel coverage of conjunctival vessels before and after administration (60 minutes after eye drop) | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in pixel coverage of conjunctival blood vessels before and after administration (after 15 minutes and 120 minutes of eye drop) Questionnaire on hyperemia (0 minutes, 15 minutes, 60 minutes, 120 minutes after eye drop) (evaluated by Visual Analogue Scale VAS) Questionnaire on comfort of use (Numerical Rating Scale NRS) Intraocular pressure (0 min and 120 min after eye drop) (Instrument used iCare IC200 TA031) Safety (occurrence of adverse events and serious adverse events) | — |
Contacts
Public ContactKana Tokumo
Hiroshima University Hospital
Outcome results
None listed