UMIN-CTR Clinical Trial

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