UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033147 |
|---|---|
| Receipt number | 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 17:09:50 |
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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
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
matuzo3a@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
