Study on the Safety of Rho-kinase Inhibitor (Ripasudil) with Needling

JRCT ID: jRCTs061220032

Registered date:09/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Glaucoma
• Date of first enrollment: 05/08/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Ripasudil (Glanatec ophthalmic solution 0.4%) 1 drop twice daily for 3 months.

Outcome(s)

• Primary Outcome: Incidence of ocular (one or both eyes) and other adverse reactions

Secondary Outcome

(1) Glaucoma type and incidence of adverse events and adverse drug reactions locally (regardless of whether it is in one or both eyes) and systemically.
(2) Pre-treatment and medications in use for ocular diseases (ocular and systemic), and incidence of adverse events and adverse reactions locally (whether in one or both eyes) and systemically.
(3) Survival rate at 3 months after needling
1) Absolute success is defined as two consecutive IOP reductions of less than 20% compared to the pre-needling level.
2) Relative success is defined as an IOP of (A) 4 mmHg or greater but less than 22 mmHg, (B) 4 mmHg or greater but less than 19 mmHg, or (C) 4 mmHg or greater but less than 22 mmHg.
(4) Change of intraocular pressure, anterior chamber flare, corneal thickness, and corneal endothelial cell count, bleb score, visual field test, bleb OCT, and contents of eye drop at 1 week, 1 month, and 3 months before and after needling.
(5) Change of intraocular pressure, anterior chamber flare, corneal thickness, and corneal endothelial cell count, bleb score, visual field test, bleb OCT, and contents of eye drop at 1 week, 1 month, and 3 months before and after needling by glaucoma type.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The study will be open to those who confirm all of the following criteria
(1) Patients undergoing needling at least 3 months after trabeculectomy.
(2) Patients must be at least 20 years of age at the time of consent.
(3) Patients who can make outpatient visits for 3 months after needling.
(4) Patients who can write consent to participate in this study.

Exclude criteria

Patients who relevant to any of the following criteria are not eligible for this study.
(1) Pregnant, lactating or possibly pregnant women.
(2) Patients who have difficulty measuring intraocular pressure with a Goldmann applanation tonometer.
(3) Patients with allergy to Ripasudil.
(4) Patients less than 3 months post-internal eye surgery (except for cataract surgery performed at the same time with trabeculectomy).
(5) Patients with a history of conjunctival surgery (except for trabeculectomy).
(6) Patients who have received eye drops or oral medication containing tranilast at least 30 days prior to the start of the study.
(7) Patients receiving ripasudil ophthalmic solution at least 3 days prior to the start of the study
(8) Other patients deemed inappropriate by the principal investigator/approving ophthalmologist to conduct this study.
(9) Patients who are participating or intend to participate in other clinical studies while participating in this study.

Related Information

• Primary Sponsor: Mizuno Yu