Effects of Ripasudil-brimonidine fixed-dose Combination using rho Kinase inhibitor and alpha2 adrenergic receptor agonist on aqueous column in the episcleral vein: a randomized, double-masked crossover clinical trial (ROCK alpha-aqua)

JRCT ID: jRCTs051240091

Registered date:17/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Health adults
• Date of first enrollment: 02/08/2024
• Target sample size: 24
• Study type: Interventional

Intervention(s)

Test drugs are GLA-ALPHA combination ophthalmic solution and Ailamide combination opthalmic suspension and Aiphagan opthalmic suspension.
One of the test drugs will be instilled in the eye to be evaluated in a single dose (1 drop per day), followed by a single drop of the other eye drop (1 drop per day) at least 2 days later, followed by a single drop of the last eye drop (1 drop per day) at least 2 days later.

Outcome(s)

• Primary Outcome: Aqueous column changes in the episcleral veins 2 hours after instillation of ripasudil versus latanoprost
• Secondary Outcome: Aqueous column changes in the episcleral veins 8 hours after instillation, intraocular pressure changes (2 and 8 hours after instillation), questionnaire: Score evaluation of usability (eye irritation, blurred vision, conjunctival congestion, bitter taste), adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Received sufficient explanation for participation and have obtained the subject's free and voluntary written consent.
2)Healthy adults over 18 years old, regardless of gender

Exclude criteria

1)Participation in this study is deemed inappropriate by the principal investigator
2)Eye diseases
3)Impossibility observing aqueous veins
4)Pregnant, breastfeeding, may be pregnant, or wish to become pregnant during the research period

Related Information

• Primary Sponsor: Inatani Masaru
• Source(s) of Monetary Support: Kowa Company,LTD