UMIN-CTR Clinical Trial

Basic information
Public title	Daily disposable silicone hydrogel contact lens survey.
Acronym	Daily disposable silicone hydrogel contact lens comfort.
Scientific Title	Daily disposable silicone hydrogel contact lens survey.
Scientific Title:Acronym	Daily disposable silicone hydrogel contact lens comfort.
Region	Japan

Condition
Condition	Myopia and Myopic astigmatism
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Daily disposable silicone hydrogel contact lens comfort assessment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity and questionnaire about comfort.
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Wearing contact lenses.
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	15 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Aged 15 to 40 years old. 2.Subjects who are able to understand an informed consent form, in the case of minors younger than twenty, consent is obtained from their parents. 3.Subjects to whom the study lens can be prescribed within the power range. 4.Subjects with a CL corrected visual acuity of 0.7 or higher to whom the lens is a good fit. 5.Subjects who wear CL on both eyes for at least 8 hours per day and 7 days per week. 6.Subjects who have no health conditions that would be a problem for the usage of CL.
Key exclusion criteria	1.Subjects who wear a contact lens in only one eye. 2.Subjects with aphakia or eyes implanted with artificial intraocular lenses. 3.Subjects with systemic diseases that may affect the eyes. 4.Subjects using drugs that may affect visual function and CL performance. 5.Subjects with keratoconus, corneal infiltration, or corneal ulcer. 6.Subjects who have undergone corneal surgery refractive surgery, etc. 7.Subjects who are participating in other clinical studies or clinical trials, or who have participated in studies or trials in the past 30 days. 8.Subjects who the researcher in charge of the clinical trial deems unsuitable.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Tojima
Organization	Nitten Pharmaceutical Co.,Ltd
Division name	Surgical Business Promotion Division
Zip code	105-9912
Address	2-8-13 daimon,minato-ku,Tokyto,105-0012 Japan
TEL	03-5408-5305
Email	h-tojima@nitten-eye.co.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Tojima
Organization	Nitten Pharmaceutical Co.,Ltd
Division name	Surgical Business Promotion Division
Zip code	105-9912
Address	2-8-13 daimon,minato-ku,Tokyto,105-0012 Japan
TEL	03-5408-5305
Homepage URL
Email	h-tojima@nitten-eye.co.jp

Sponsor
Institute	Nitten Pharmaceutical Co.,Ltd
Institute
Department

Funding Source
Organization	Nitten Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	ROHTO NITTEN Co., Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Heishinkai OPHAC Hospital
Address	4-1-29 miyahara , yodogawa-ku , Osaka , 532-0002 Japan
Tel	06-6395-9000
Email	sumiko.kawamoto@heishinkai.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

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 14 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	20
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	2022 Year 02 Month 04 Day
Date of IRB	2022 Year 02 Month 24 Day
Anticipated trial start date	2022 Year 03 Month 14 Day
Last follow-up date	2022 Year 04 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	2022 Year 03 Month 14 Day
Last modified on	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053803