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Quantitative evaluation of ROCK inhibitor and a2 adrenoceptor agonist inducing conjunctival hyperemia study
(ROCKa-hy study)

Evaluation of ROCK inhibitor and a2 adrenoceptor agonist inducing conjunctival hyperemia study (ROCKa-hy study)

Kazuyuki Hirooka

Hiroshima University Hospital

1-2-3 Kasumi, Minami-ku,Hiroshima-shi, Hiroshima

kazuyk@hiroshima-u.ac.jp

Tokumo Kana

Hiroshima University Hospital

1-2-3 Kasumi, Minami-ku,Hiroshima-shi, Hiroshima

+81-82-257-5247

kanatokumo@hiroshima-u.ac.jp

Recruiting

Sept. 03, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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 .

Both

open-angle glaucoma

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 performed at 0, 15, 60, and 120 minutes after the ophthalmic drops (Visit 2).
Eight weeks after switching to ripasudil/brimonidine ophthalmic solution, patients receive 1 drop of ripasudil/brimonidine ophthalmic solution once, and anterior segment photographs are taken at 0, 15, 60 and 120 minutes after the ophthalmic drops (Visit 3). Pixel coverage of conjunctival vessels will be calculated using image analysis software.
Secondary questionnaires on hyperemia (evaluated by Visual Analogue Scale: VAS), comfort of use (evaluated by Numerical Rating Scale: NRS), and intraocular pressure measurement using an iCare hand-held tonometer will be conducted.

glaucoma

eye drop

D005902

Difference in pixel coverage of conjunctival vessels before and after administration (60 minutes after eye drop)

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)

+81-82-257-1551

May. 29, 2024

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