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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041107
Receipt No. 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

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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
Email 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
Email mimurat@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

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
Email 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
URL(English) https://upload.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


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