NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051240091

Registered date:17/07/2024

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)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHealth adults
Date of first enrollment02/08/2024
Target sample size24
Countries of recruitment
Study typeInterventional
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 OutcomeAqueous column changes in the episcleral veins 2 hours after instillation of ripasudil versus latanoprost
Secondary OutcomeAqueous 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 maximumNot applicable
GenderBoth
Include criteria1)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 criteria1)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

Contact

Public contact
Name Masaru Inatani
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan Fukui Japan 910-1193
Telephone +81-776-61-8403
E-mail inatani@u-fukui.ac.jp
Affiliation University of Fukui Hospital
Scientific contact
Name Masaru Inatani
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan Fukui Japan 910-1193
Telephone +81-776-61-8403
E-mail inatani@u-fukui.ac.jp
Affiliation University of Fukui Hospital