UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041987 |
|---|---|
| Receipt number | R000047922 |
| Scientific Title | Investigation of the factors determining contact lens discomfort |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2021/03/06 17:38:25 |
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Basic information
Public title
Investigation of the factors determining contact lens discomfort
Acronym
Investigation of the factors determining contact lens discomfort
Scientific Title
Investigation of the factors determining contact lens discomfort
Scientific Title:Acronym
Investigation of the factors determining contact lens discomfort
Region
| Japan |
Condition
Condition
Contact lens discomfort
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the factors determining contact lens discomfort
Basic objectives2
Others
Basic objectives -Others
Investigation of the relationship between the degree of contact lens discomfort and tear-film related parameters
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Contact lens discomfort associated symptoms (J-CLDEQ-8 & visual analog scale)
Key secondary outcomes
Before wearing and at the point of 15 min after wearing soft contact lens
1: The radius of tear meniscus
2: The pattern of tear film breakup
3: Non-invasive breakup time of tear film
4: The index which assess the expansion of tear film breakup
5: Distortion value of Mayer's rings of corneal topography
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Soft contact lens user with contact lens discomfort
Key exclusion criteria
1: The patients with ocular surface inflammatory disease, blepharitis (including meibomitis), and meibomian gland dysfunction
2: The patient who experienced ocular surgery (including eyelid surgery) within 3 months prior to the day of entry
3: 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 | Norihiko |
| Middle name | |
| Last name | Yokoi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
6020841
Address
465 Kajii-cho Hirokoji-agaru Kawaramachi-dori Kamigyo-ku, Kyoto, Japan
TEL
075-251-5578
nyokoi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Norihiko |
| Middle name | |
| Last name | Yokoi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
6020841
Address
465 Kajii-cho Hirokoji-agaru Kawaramachi-dori Kamigyo-ku, Kyoto, Japan
TEL
075-251-5578
Homepage URL
nyokoi@koto.kpu-m.ac.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
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465 Kajii-cho Hirokoji-agaru Kawaramachi-dori Kamigyo-ku, Kyoto, Japan
Tel
075-251-5111
kpu@esct.bvits.com
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
京都府立医科大学（Kyoto Prefectural University of Medicine）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047922
