UMIN-CTR Clinical Trial

Basic information
Public title	Study for intraocular pressure elevation after glaucoma surgery
Acronym	Study for intraocular pressure elevation after glaucoma surgery
Scientific Title	Prospective comparative study between rispadil and brinzolamide in glaucoma for intraocular pressure elevation after trabeculotomy ab interno
Scientific Title:Acronym	RB study
Region	Japan

Condition
Condition	Primary open angle glaucoma and exfoliative glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	MIGS (minimally invasive glaucoma surgery) is less invasive than conventional glaucoma surgeries and getting popular these days. A Kahook dual blade (KDB) is a MIGS device, especially for trabeculotomy ab interno. One of the complications after trabeculotomy including trabeculotomy ab interno with KDB (KDB-trabeculotomy) is a transient intraocular pressure (IOP) increase (IOP spike). The frequency is about 5% and IOP spike is a risk factor for the progression of visual field impairment. Therefore, suppressing postoperative intraocular pressure spikes is important. IOP-lowering drugs are administered against the IOP elevation after surgery, however, anti-biotics and anti-inflammation drops are essential after surgery, so it is required to minimize drops to control the IOP.The purpose of this study is to compare two medications which have different mechanisms of action on aqueous humor outflow pathway, Ripasudil (a specific Rho-kinase inhibitor) and Brinzolamide (a carbonic anhydrase inhibitor), and assess their efficacy and safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Level of IOP at 1 day, 1 week, 1 month, and 3 months after surgery
Key secondary outcomes	Visual acuity, number and thickness of corneal endothelium, visual field, gonioscopy, doing condition and safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ripasudil eye drop is administrated twice daily until 3 months after surgery.
Interventions/Control_2	Brinzolamide eye drop is administrated twice daily until 3 months after surgery.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects are adult patients with primary open angle glaucoma or exfoliative glaucoma who approved as an indication for KDB-trabeculotomy at a preoperative conference and obtained the consent for this study in the document at the Kumamoto University Hospital and whose IOP at 1 day after surgery is 12 mmHg or higher.
Key exclusion criteria	Exclusion criteria are cases who have difficulty obtaining consent for this study due to mental diseases, or reliable inspection data e.g. due to corneal diseases, who have a contraindication for Ripasuril and Brimonidine, and whose IOP is 20 mmHg or more at 1 day after surgery.
Target sample size	172

Research contact person
Name of lead principal investigator	1st name Toshihiro Middle name Last name Inoue
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Ophthalmology
Zip code	860-8556
Address	1-1-1 Honjo, Chuo-ku, Kumamoto-city
TEL	+81963735247
Email	noel@da2.so-net.ne.jp

Public contact
Name of contact person	1st name Eri Middle name Last name Takahashi
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Ophthalmology
Zip code	860-8556
Address	1-1-1 Honjo, Chuo-ku, Kumamoto-city
TEL	+81963735247
Homepage URL
Email	eritakahashi@kumamoto-u.ac.jp

Sponsor
Institute	Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kumamoto University
Address	1-1-1, Honjo, Chuo-ku, Kumamoto city
Tel	+81963735247
Email	ganka@kumamoto-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 11 Month 30 Day
Date of IRB	2020 Year 11 Month 30 Day
Anticipated trial start date	2021 Year 01 Month 04 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 27 Day
Last modified on	2020 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048143

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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