UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060845 |
|---|---|
| Receipt number | R000069622 |
| Scientific Title | Assessment of QUAlity of eye-RElated Life and vision in subjects using single-use vision-correcting soft contact LEns wear |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 11:49:23 |
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Basic information
Public title
Assessment of QUAlity of eye-RElated Life and vision in subjects using single-use vision-correcting soft contact LEns wear
Acronym
Assessment of QUAlity of eye-RElated Life and vision in subjects using single-use vision-correcting soft contact LEns wear
Scientific Title
Assessment of QUAlity of eye-RElated Life and vision in subjects using single-use vision-correcting soft contact LEns wear
Scientific Title:Acronym
Assessment of QUAlity of eye-RElated Life and vision in subjects using single-use vision-correcting soft contact LEns wear
Region
| Japan |
Condition
Condition
Myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the efficacy and safety of switching patients from other daily disposable hydrogel contact lenses to Bausch+ Lomb Aqualox 1-Day UVSHIN.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Questionnaire(VAS)
2.j-CLDEQ-8
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 18 years or older at the time of consent acquisition.
2.Individuals who, prior to prescription of the study product, had used identical daily disposable hydrogel soft contact lenses (other products) in both eyes for at least 3 months, wearing them at least 4 days per week for 8 hours or more per day.
3.Individuals who are already using the study product in both eyes.
4.Individuals with a cylinder power of less than 1.25D in the fully corrected refractive error during the subjective refraction test at the time of prescribing the study product.
5.Individuals achieving a corrected distance visual acuity of 0.7 or better in one eye with the study product.
6.Individuals who understand the purpose of this study and have personally signed the consent form for participation.
Key exclusion criteria
1.Individuals with systemic diseases or ocular diseases (cataracts, glaucoma, macular diseases) that may affect the results, or those with a history of eye surgery (including laser surgery).
2.Individuals who used hard contact lenses within 30 days prior to starting use of the study product.
3.Individuals who used multiple products within 3 months prior to starting use of the study product.
4.Individuals who have used the study product for 30 days or more.
5.Individuals using eye drops for the purpose of alleviating or treating hay fever symptoms.
6.Individuals with a conflict of interest with this study or the research institution.
7.Individuals requiring a proxy decision-maker.
8.Other individuals deemed unsuitable for study participation by the investigator or others.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Maeda |
| Middle name | |
| Last name | Naoyuki |
Organization
Kozaki eye clinic
Division name
Ophthalmology
Zip code
545-0021
Address
1-51-10 Hannancho Abeno-ku, Osaka-shi, Osaka-fu
TEL
06-6621-2174
maeda@kozaki-ganka.jp
Public contact
Name of contact person
| 1st name | Maeda |
| Middle name | |
| Last name | Naoyuki |
Organization
Kozaki eye clinic
Division name
Ophthalmology
Zip code
545-0021
Address
1-51-10 Hannancho Abeno-ku, Osaka-shi, Osaka-fu
TEL
06-6621-2174
Homepage URL
maeda@kozaki-ganka.jp
Sponsor or person
Institute
Kozaki eye clinic
Institute
Department
Personal name
Funding Source
Organization
B.L.J. Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.or.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 | 03 | Month | 06 | 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
38
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
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069622
