UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031804 |
|---|---|
| Receipt number | R000036308 |
| Scientific Title | Analysis of the pre-lens tear film dynamics in soft contact lenses |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2022/09/18 22:24:40 |
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Basic information
Public title
Analysis of the pre-lens tear film dynamics in soft contact lenses
Acronym
Analysis of the pre-lens tear film dynamics
Scientific Title
Analysis of the pre-lens tear film dynamics in soft contact lenses
Scientific Title:Acronym
Analysis of the pre-lens tear film dynamics
Region
| Japan |
Condition
Condition
Soft contact lens wearer with refractive complication
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the in vivo method of evaluating the pre-lens tear film dynamics in soft contact lenses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At the point of 15 min after wearing daily disposable soft contact lens
1)The curvature radius of tear meniscus
2)The pattern of tear breakup
3)Non-Invasive Breake Up Time
4)The index which assess the extension of tear breakup
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
prescribe the soft contact lens (DAILIES TOTAL 1)
Evaluate the tear film dynamics by DR-1 tear specular scope and Video menisco-metry
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)The patient diagnosed dry eye before wearing soft contact lens.
2)Having provided voluntary written consent for participation in this study.
Key exclusion criteria
1)The patient diagnosed dry eye without soft contact lens wearing
2)The patient who was performed ocular surgery within 3 month prior to the day of entry
3)Th patient who diagnosed as ocular surface disease influenced the results of exam such as allergy conjunctivitis
4)Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoke Norihiko |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 Kawaramachi Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5578
nyokoi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itoi Motohiro |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 Kawaramachi Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5578
Homepage URL
info@ganka.gr.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 01 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2022 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036308
