UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063351 |
|---|---|
| Receipt number | R000072509 |
| Scientific Title | Longitudinal Changes in Aqueous Humor Outflow Facility Following Initiation of Ripasudil in Patients with Glaucoma: A Single-Center Prospective Observational Study |
| Date of disclosure of the study information | 2026/10/22 |
| Last modified on | 2026/10/20 15:13:36 |
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Basic information
Public title
Changes in Aqueous Humor Outflow Facility Following Ripasudil Eye Drop Treatment
Acronym
Ripasudil Outflow Study
Scientific Title
Longitudinal Changes in Aqueous Humor Outflow Facility Following Initiation of Ripasudil in Patients with Glaucoma: A Single-Center Prospective Observational Study
Scientific Title:Acronym
Ripasudil Outflow Study
Region
| Japan |
Condition
Condition
Primary open-angle glaucoma (including normal-tension glaucoma)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate longitudinal changes in aqueous humor outflow facility (C-value) before and after initiation of ripasudil eye drops in patients with primary open-angle glaucoma, including normal-tension glaucoma, and to investigate the association between changes in outflow facility and intraocular pressure reduction.
Basic objectives2
Others
Basic objectives -Others
An exploratory study to investigate changes in aqueous humor outflow facility following ripasudil treatment and their association with intraocular pressure reduction.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Longitudinal changes in aqueous humor outflow facility (C-value) from baseline to 3 months after initiation of ripasudil eye drops. Outflow facility will be assessed at baseline (the mean of two pretreatment measurements), 2 weeks, 1 month, and 3 months after treatment initiation.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1. Patients diagnosed with primary open-angle glaucoma or normal-tension glaucoma at the Department of Ophthalmology, Toyama University Hospital.
2. Patients for whom initiation of ripasudil eye drops has been decided as part of routine clinical care.
3. Patients aged 20 years or older.
4. Patients who can undergo intraocular pressure measurement using Goldmann applanation tonometry and aqueous humor outflow facility (C-value) measurement using a pneumatonometer.
5. Patients who have provided voluntary written informed consent after receiving sufficient information about the study.
Key exclusion criteria
1. History of glaucoma surgery.
2. History of laser trabeculoplasty.
3. History of cyclophotocoagulation.
4. Corneal disease or corneal opacity that interferes with intraocular pressure measurement using Goldmann applanation tonometry or aqueous humor outflow facility (C-value) measurement using a pneumatonometer.
5. History of hypersensitivity to ripasudil eye drops.
6. Patients considered unsuitable by the principal investigator or study investigators because of severe systemic disease, ocular comorbidities, inability to maintain a supine position during examination, or other conditions that may interfere with safe C-value measurement or completion of scheduled study assessments.
7. Patients with severe corneal epithelial damage that may be aggravated by tonography.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hayashi |
Organization
Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name
Department of Ophthalmology
Zip code
930-0194
Address
2630 Sugitani, Toyama City
TEL
0764347363
ahayashi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuya |
| Middle name | |
| Last name | Otsuka |
Organization
Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name
Department of Ophthalmology
Zip code
930-0194
Address
2630 Sugitani, Toyama City
TEL
0764347363
Homepage URL
otsuka@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
Research Ethics Committee for Clinical and Epidemiological Research of Toyama University
Address
2630 Sugitani, Toyama City
Tel
076-415-8857
rinri@adm.u-toyama.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
| 2026 | Year | 10 | Month | 22 | 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
| 2026 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study involving 30 patients (30 eyes) with primary open-angle glaucoma or normal-tension glaucoma for whom initiation of ripasudil eye drops has been determined as part of routine clinical care. Initiation, continuation, or discontinuation of ripasudil and any changes in other glaucoma treatments will be determined by the treating ophthalmologist independently of study participation. No study-directed therapeutic intervention will be performed.
Aqueous humor outflow facility (C-value) will be measured using a pneumatonometer as an additional study-specific assessment. Two baseline measurements will be obtained on separate days within 14 days before treatment initiation, and their mean will be used as the baseline value. Follow-up measurements will be performed at approximately 2 weeks, 1 month, and 3 months after treatment initiation. Post-treatment measurements will generally be performed between 1 and 3 hours after the last ripasudil instillation without modifying the patient's usual dosing schedule. The times of the last instillation and C-value measurement will be recorded.
The primary outcome is the longitudinal change in C-value from baseline to 3 months, analyzed using a linear mixed-effects model. The association between changes in C-value and intraocular pressure reduction will also be explored. Any changes in glaucoma treatment during follow-up will be documented, and C-value measurements obtained after treatment changes will be excluded from the primary analysis.
Management information
Registered date
| 2026 | Year | 10 | Month | 20 | Day |
Last modified on
| 2026 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072509
