UMIN-CTR Clinical Trial

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
Email	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
Email	info@ganka.gr.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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036308