UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of subjective comfort and lens fit characteristics of daily disposable silicone hydrogel contact lenses (Precision 1) in first time contact lens wearing.
Acronym	Subjective comfort of daily disposable silicone hydrogel contact lenses in first time contact lens wearing.
Scientific Title	Evaluation of subjective comfort and lens fit characteristics of daily disposable silicone hydrogel contact lenses (Precision 1) in first time contact lens wearing.
Scientific Title:Acronym	Subjective comfort of daily disposable silicone hydrogel contact lenses in first time contact lens wearing.
Region	Japan

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

Objectives
Narrative objectives1	To investigate subjective comfort and lens fit characteristics of Precision 1 in first-time CL users.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Corrective visual acuity 2)Lens centration/ fit 3)Subjective comfort 4)Subjective vision (QOV) 5)Convenience in wearing and removal of study lenses
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	13 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Aged 13 to 40 years old must sign the informed consent. 2. Habitual eyeglasses wearers for vision correction and have never worn any contact lenses prior to enroll this clinical study. 3. Required lenses within the power range of study lenses to be fitted (-0.50D to -6.00D). 4. Vision correctable 0.8 (20/25) or better in each eye at distance with pre-study contact lenses at Baseline. 5. Have interest in wearing contact lenses as "very interested" or "fairly interested" and are willing to wear contact lenses for at least 8 hours per day and 5 days per week.
Key exclusion criteria	1. Subjects with systemic diseases or ocular diseases, including dry eyes. 2. Subjects with a history of eye surgery/trauma local or systemic antibiotic or corticosteroid, immunomodulatory current medication, pregnancy or breastfeeding within 6 months of the enrollment visit. 3. Monocular subjects (only one eye with functional vision) or subjects fit with only one lens. 4. Participation in any clinical trial within 30 days of the enrollment visit. 5. Patient who in judged ineligible as patients in this clinical study by the investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Mimura
Organization	Teikyo University
Division name	School of Medicine, Department of Ophthalmology
Zip code	173-8605
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL	03-3964-1211
Email	mimurat@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Mimura
Organization	Teikyo University
Division name	School of Medicine, Department of Ophthalmology
Zip code	173-8605
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL	03-3964-1211
Homepage URL
Email	mimurat@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	Teikyo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nerima West Eye Clinic
Name of secondary funder(s)	Alcon Japan Ltd.

IRB Contact (For public release)
Organization	Teikyo University
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
Tel	03-3964-1211
Email	mimurat@med.teikyo-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 10 Month 28 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 26 Day
Date of IRB	2020 Year 10 Month 13 Day
Anticipated trial start date	2020 Year 10 Month 26 Day
Last follow-up date	2023 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 10 Month 28 Day
Last modified on	2020 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048253