UMIN-CTR Clinical Trial

Basic information
Public title	The influence of corneal epithelium barrier function caused by wearing tinted contact lenses
Acronym	The influence of cornea caused by tinted contact lenses
Scientific Title	The influence of corneal epithelium barrier function caused by wearing tinted contact lenses
Scientific Title:Acronym	The influence of cornea caused by tinted contact lenses
Region	Japan

Condition
Condition	ametropia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluation of corneal epithelium barrier functional disorder caused by tinted contact lenses
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	measurement of cornea barrier functional disorder using FL-500 after 6 hours contact lens wear
Key secondary outcomes	To observe of corneal changes using anterior optical coherence tomography before and after the six hours lens wearing. Evaluation of superficial punctate keratopathy after six hours lens wearing. Observation of the lens using the electric microscope

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	wearing the contact lenses six hours
Interventions/Control_2	measuring corneal epithelium barrier function after take off the contact lenses
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	The patient without complications other than ametropia. The patient that it was understood enough after having received enough explanation, and a document agreement by the free will was provided.
Key exclusion criteria	The patient had highly decreased tear. Patient having basic disease to cause a cornea disorder. The patient with the past of the ophthalmological surgery. The patient using eye drops for treating dry eye. The patient having corneal disorder. The patient have never put on the contact lenses.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Akiko Middle name Last name Mastuzawa
Organization	Kawasaki Municipal Tama hospital
Division name	Ophthalmology
Zip code	2148525
Address	1-30-37,Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL	0449338111
Email	matuzo3a@marianna-u.ac.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Mastuzawa
Organization	Kawasaki Municipal Tama hospital
Division name	Ophthalmology
Zip code	2148525
Address	1-30-37,Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL	0449338111
Homepage URL
Email	matuzo3a@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Kawasaki Municipal Tama hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	St. Marianna University School of Medicine
Address	2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa
Tel	0449778111
Email	matuzo3a@marianna-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	聖マリアンナ医科大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 27 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	2016 Year 05 Month 20 Day
Date of IRB	2014 Year 05 Month 20 Day
Anticipated trial start date	2016 Year 05 Month 20 Day
Last follow-up date	2020 Year 09 Month 30 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 06 Month 26 Day
Last modified on	2019 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037691