UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061452 |
|---|---|
| Receipt number | R000070317 |
| Scientific Title | Clinical Evaluation of Disposable Silicone Hydrogel Contact Lenses |
| Date of disclosure of the study information | 2026/05/04 |
| Last modified on | 2026/05/04 14:42:39 |
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Basic information
Public title
Clinical Evaluation of Disposable Silicone Hydrogel Contact Lenses
Acronym
Clinical Evaluation of Disposable Silicone Hydrogel Contact Lenses
Scientific Title
Clinical Evaluation of Disposable Silicone Hydrogel Contact Lenses
Scientific Title:Acronym
Clinical Evaluation of Disposable Silicone Hydrogel Contact Lenses
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the comfort of disposable silicone hydrogel contact lenses among current contact lens wearers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Corrected visual acuity
2)Lens centration/ fit
3)BUT
4)Subjective questionnaires (comfort, vision, handling, dry eye symptoms)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing contact lenses
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
| 13 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Aged 13 to 60 years old must sign the informed consent.
2.Habitual soft/ silicone hydrogel contact lenses wearers.
3.Requiring lenses within the power range of both study contact lenses to be fitted (-0.50D to -6.00D).
4.Vision correctable 0.8 (20/25) or better in each eye at distance with pre-study contact lenses at Baseline.
5.Have subjective symptoms of contact lens discomfort as defined by the Symptomatology eligibility questionnaires.
Key exclusion criteria
Subjects with systemic diseases will be excluded. Subjects with a history of ophthalmic surgery or trauma within 6 months of study enrollment, or who have used topical or systemic antibiotics or corticosteroids, immunomodulators, or who are pregnant or breastfeeding, will also be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Mimura |
Organization
Department of Ophthalmology, Tsurumi University School of Dentistry
Division name
Department of Ophthalmology, Tsurumi University School of Dentistry
Zip code
230-8501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama, Kanagawa 230-8501
TEL
045-580-8500
mimurat-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Mimura |
Organization
Tsurumi University School of Dentistry
Division name
Department of Ophthalmology
Zip code
230-8501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama, Kanagawa 230-8501
TEL
045-580-8500
Homepage URL
mimurat-tky@umin.ac.jp
Sponsor or person
Institute
Tsurumi University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tsurumi University School of Dentistry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Teikyo University, Nerima Station West Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
Tel
03-3964-1211
mimurat-tky@umin.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 | 05 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 05 | Month | 04 | Day |
Last modified on
| 2026 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070317
