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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033147
Receipt No. R000037691
Scientific Title The influence of corneal epithelium barrier function caused by wearing tinted contact lenses
Date of disclosure of the study information 2018/06/27
Last modified on 2019/07/08

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Basic information
Public title The influence of corneal epithelium barrier function caused by wearing tinted contact lenses
Acronym The influence of cornea caused by tinted contact lenses
Scientific Title The influence of corneal epithelium barrier function caused by wearing tinted contact lenses
Scientific Title:Acronym The influence of cornea caused by tinted contact lenses
Region
Japan

Condition
Condition ametropia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluation of corneal epithelium barrier functional disorder caused by tinted contact lenses
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measurement of cornea barrier functional disorder using FL-500 after 6 hours contact lens wear
Key secondary outcomes To observe of corneal changes using anterior optical coherence tomography before and after the six hours lens wearing.
Evaluation of superficial punctate keratopathy after six hours lens wearing.
Observation of the lens using the electric microscope

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 wearing the contact lenses six hours
Interventions/Control_2 measuring corneal epithelium barrier function after take off the contact lenses
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria The patient without complications other than ametropia.
The patient that it was understood enough after having received enough explanation, and a document agreement by the free will was provided.
Key exclusion criteria The patient had highly decreased tear.
Patient having basic disease to cause a cornea disorder.
The patient with the past of the ophthalmological surgery.
The patient using eye drops for treating dry eye.
The patient having corneal disorder.
The patient have never put on the contact lenses.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Mastuzawa
Organization Kawasaki Municipal Tama hospital
Division name Ophthalmology
Zip code 2148525
Address 1-30-37,Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL 0449338111
Email matuzo3a@marianna-u.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Mastuzawa
Organization Kawasaki Municipal Tama hospital
Division name Ophthalmology
Zip code 2148525
Address 1-30-37,Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL 0449338111
Homepage URL
Email matuzo3a@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization Kawasaki Municipal Tama hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Marianna University School of Medicine
Address 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa
Tel 0449778111
Email matuzo3a@marianna-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 聖マリアンナ医科大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 27 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
2016 Year 05 Month 20 Day
Date of IRB
2014 Year 05 Month 20 Day
Anticipated trial start date
2016 Year 05 Month 20 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 26 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037691

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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