UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041107 |
|---|---|
| Receipt number | R000046944 |
| Scientific Title | Evaluation of comfort in wearing contact lenses |
| Date of disclosure of the study information | 2020/07/15 |
| Last modified on | 2020/07/15 10:33:24 |
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Basic information
Public title
Evaluation of comfort in wearing contact lenses
Acronym
Evaluation of wearing contact lenses
Scientific Title
Evaluation of comfort in wearing contact lenses
Scientific Title:Acronym
Evaluation of wearing contact lenses
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate comfort when wearing contact lenseses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity and questionnaire about comfort
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
First wearing of contact lenses or switching of lenses
Interventions/Control_2
Control
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
myopic eye
Key exclusion criteria
Patients with a past history of ocular surgery.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Mimura |
Organization
Teikyo University
Division name
School of Medicine, Department of Ophthalmology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL
03-3964-1211
mimurat@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Mimura |
Organization
Teikyo University
Division name
School of Medicine, Department of Ophthalmology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL
03-3964-1211
Homepage URL
mimurat@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
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
Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
Tel
03-3964-1211
mimurat@med.teikyo-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
| 2020 | Year | 07 | Month | 15 | 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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 07 | Month | 15 | Day |
Last modified on
| 2020 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046944
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
