Evaluation of conjunctival hyperemia in switching from Lipasudil to Lipasudil Brimonidine

JRCT ID: jRCTs061240050

Registered date:03/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: primary open-angle glaucoma
• Date of first enrollment: 03/09/2024
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Obtain written consent from potential subjects (Visit 1). Patients who are confirmed eligible will receive one drop of Lipasudil 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 lipasudil/brimonidine ophthalmic solution, patients receive 1 drop of lipasudil/brimonidine ophthalmic solution once, and anterior segment photographs are taken at 0 minutes, 15 minutes, 60 minutes, 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.

Outcome(s)

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

Secondary Outcome

Difference in pixel coverage of conjunctival blood vessels before and after administration (after 15 minutes and 120 minutes of eye drop)
Questionnaire on bloodshot (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)

Key inclusion & exclusion criteria

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

Include criteria

Patients with primary open-angle glaucoma(broad definition) who are using Lipasudil ophthalmic solution for glaucoma eye drop treatment and need intensified treatment

Selection Criteria
Patients 18 years of age or older with primary open-angle glaucoma (broad definition) who require additional glaucoma treatment due to inadequate IOP reduction with prior glaucoma eye drops. 2.
2. patients who have been receiving Lipasudil 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

Exclude criteria

1. patients using ophthalmic solutions containing brimonidine tartrate within 4 weeks of the first hyperemia evaluation date (Visit 2)
2. patients with a history of hypersensitivity to lipasudril hydrochloride hydrate, brimonidine tartrate,anhydrous sodium dihydrogen phosphate, sodium chloride, glycerin, sodium hydroxide, or concentrated benzalkonium chloride solution 50
Pregnant, parturient, or lactating women
4. patients with secondary glaucoma (excluding dropsy glaucoma) and patients with angle closure glaucoma
5. patients who have difficulty measuring intraocular pressure with iCare
6. patients with concomitant ocular trauma
Patients with anterior segment inflammatory disease with hyperemia
Patients who are unable to have anterior segment photographs taken. 9.
Patients with a history of internal ophthalmic surgery within 6 months of the first hyperemia evaluation (Visit 2) 10.
10. contact lens wearers
11.Patients who are deemed by the investigator to be inappropriate for this study.

Related Information

• Primary Sponsor: Kazuyuki Hirooka
• Secondary Sponsor: Kowa Company.LTD