UMIN-CTR Clinical Trial

Basic information
Public title	Association between subjective symptom and changes in lens surface in soft contact lens wearers
Acronym	Subjective symptom and changes in lens surface
Scientific Title	Association between subjective symptom and changes in lens surface in soft contact lens wearers
Scientific Title:Acronym	Subjective symptom and changes in lens surface
Region	Japan

Condition
Condition	Soft contact lens wearer
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Wearing soft contact lens makes it easier to complain of discomfort (Contact lens discomfort:CLD). Relevant factors suspected tear film stability, lid wiper epitheliopathy and tear coponent on contact lens. The aim of this study is to investigate the factors related to various subjective symptoms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	subjective symptom noninvasive rear break-up time Tear components on soft contact lens
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	soft contact lens
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	45 years-old >=
Gender	Male and Female
Key inclusion criteria	soft contact lens wearers
Key exclusion criteria	ocular disease systemic disease
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Itokawa
Organization	Toho university medical center
Division name	Ophthalmology
Zip code	143-8541
Address	6-11-1 Omori Nishi Ota-ku, Tokyo
TEL	03-3761-4151
Email	takashi.itokawa@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Itokawa
Organization	Toho university medical center
Division name	Ophthalmology
Zip code	143-8541
Address	6-11-1 Omori Nishi Ota-ku, Tokyo
TEL	03-3761-4151
Homepage URL
Email	takashi.itokawa@med.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

Funding Source
Organization	Toho University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Toho university medical center
Address	6-11-1 Omori Nishi Ota-ku, Tokyo
Tel	03-3761-4151
Email	takashi.itokawa@med.toho-u.ac.jp

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 03 Month 26 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	40
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	Completed
Date of protocol fixation	2019 Year 02 Month 08 Day
Date of IRB	2019 Year 02 Month 08 Day
Anticipated trial start date	2019 Year 02 Month 08 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 26 Day
Last modified on	2022 Year 10 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045556