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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041987
Receipt No. 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

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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
Email 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
Email nyokoi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047922

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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