Ripasudil-brimonidine fixed-dose combination Observational study to Confirm the safety and efficacy of rho Kinase inhibitor and alpha2 adrenergic receptor agonist for long-term use in Japanese patients with glaucoma

Ripasudil-brimonidine fixed-dose combination Observational study to Confirm the safety and efficacy of rho Kinase inhibitor and alpha2 adrenergic receptor agonist for long-term use in Japanese patients with glaucoma - ROCK-alpha study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050123

Enrollment

5000

Registered

2023-01-24

Start date

2023-01-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glaucoma, ocular hypertension

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with glaucoma or ocular hypertension 2. Patients who started to use ripasudil-brimonidine fixed-dose combination in general clinical practice, and who give their consent to participate in this study within 8 weeks after the start of prescription of it 3. Patients whose intraocular pressure was measured before the the start of prescription of the ripasudil-brimonidine fixed-dose combination

Exclusion criteria

Exclusion criteria: 1. Patients who had used the ripasudil-brimonidine fixed-dose combination and had discontinued the use of it 2. Patients with a history of hypersensitivity to ripasudil or brimonidine 3. low birth weight infant, newborn infant, infant, or toddler who is younger than 2 years 4. Patients who need regal representatives to give their consent 5. Patients with other conditions that the investigators judge to be inappropriate for the study

Design outcomes

Primary

Measure	Time frame
Presence or absence of side effect by the study agent within 24 months	—

Secondary

Measure	Time frame
1. Safety evaluation endpoints 1) Presence or absence of side effect by the study agent within 3 months 2) Frequency of adverse event or side effect stratified by previous use of ripasudil or brimonidine 3) Ophthalmic adverse event or side effect related to allergy or inflammation - Frequency - Cumulative incidence of first occurrence - Cumulative incidence of first occurrence which causes the discontinuation of the study - Analysis of risk factors 2. Efficacy evaluation endpoints 1) Change and percent change of intraocular pressure from baseline to each observation point 2) Change and percent change of intraocular pressure from baseline to each observation point stratified by disease type, patients characteristics, concomitant agents, and number of concomitant agents	—

Measure

Time frame

1. Safety evaluation endpoints 1) Presence or absence of side effect by the study agent within 3 months 2) Frequency of adverse event or side effect stratified by previous use of ripasudil or brimonidine 3) Ophthalmic adverse event or side effect related to allergy or inflammation - Frequency - Cumulative incidence of first occurrence - Cumulative incidence of first occurrence which causes the discontinuation of the study - Analysis of risk factors 2. Efficacy evaluation endpoints 1) Change and percent change of intraocular pressure from baseline to each observation point 2) Change and percent change of intraocular pressure from baseline to each observation point stratified by disease type, patients characteristics, concomitant agents, and number of concomitant agents

—

Countries

Japan

Contacts

Public ContactYasunori Tomita

EviPRO Co., Ltd. Clinical Study Support Division

tomita_yasunori@evipro.co.jp03-5829-4110

Outcome results