UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051765 |
|---|---|
| Receipt number | R000058593 |
| Scientific Title | The factors associated with a visual function and ocular comfort in contact lens wearers |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/31 17:42:13 |
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Basic information
Public title
The factors associated with a visual function and ocular comfort in contact lens wearers
Acronym
Effects of contact lens on the eye
Scientific Title
The factors associated with a visual function and ocular comfort in contact lens wearers
Scientific Title:Acronym
Effects of contact lens on the eye
Region
| Japan |
Condition
Condition
Eligible participants were experienced CL wearers.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the factors associated with a visual function and ocular comfort in contact lens wearers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The factors associated with a visual function and ocular comfort in contact lens wearers.
Key secondary outcomes
Evaluation of various contact lens
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants were experienced contact lens wearers.
Key exclusion criteria
Exclusion criteria were clinically significant anterior segment or ocular surface abnormalities, ocular or systemic disease that would preclude CL wear.
Target sample size
193
Research contact person
Name of lead principal investigator
| 1st name | Nakao |
| Middle name | |
| Last name | Yoshitaka |
Organization
Kimura eye and internal medicine hospital
Division name
Department of ophthalmology
Zip code
7370029
Address
3-15 Takaramachi, Kure, Hiroshima
TEL
0823225544
yoshitaka.nakao@kimura-eye.or.jp
Public contact
Name of contact person
| 1st name | Nakao |
| Middle name | |
| Last name | Yoshitaka |
Organization
Kimura eye and internal medicine hospital
Division name
Department of ophthalmology
Zip code
7370029
Address
3-15 Takaramachi, Kure, Hiroshima
TEL
0823225544
Homepage URL
yoshitaka.nakao@kimura-eye.or.jp
Sponsor or person
Institute
Kimura eye and internal medicine hospital
Institute
Department
Personal name
Funding Source
Organization
Kimura eye and internal medicine hospital
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
Kimura eye and internal medicine hospital
Address
3-15 Takaramachi, Kure, Hiroshima
Tel
0823225544
yoshitaka.nakao@kimura-eye.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
| 2023 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study started in Kimura eye and int. med. Hospital on normal participants recruited since Jul-1-2023. The institutional board of Kimura eye and int. med. Hospital approved the study and waived the need for informed consent owing to the prospective chart review that was created for explanation of the implications of such activities and listed on a poster in the hospital.
Management information
Registered date
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058593
