UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.
Title of the study (Brief title)	Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.
Region	Japan

Condition
Condition	Habitual current daily disposable soft contact lenses wearers with symptoms of contact lens discomfort.
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this clinical study is to demonstrate non-inferiority of DAILIES TOTAL1 to 1-DAY ACUVUE TruEye for Investigator-rated successful lens centration in Japanese population.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Investigator-rated successful lens centration of Optimal after 7 to 13 days of wearing.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	DAILIES TOTAL 1, then 1-DAY ACUVUE TruEye
Interventions/Control_2	1-DAY ACUVUE TruEye, then DAILIES TOTAL 1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Must sign an informed consent form; Habitual current disposable contact lenses wearer. Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire. Lenses within power range specified in the protocol. Vision correctable to 0.8 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit 1. Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits. Other protocol-specified inclusion criteria may apply.
Key exclusion criteria	Currently wearing DAILIES TOTAL 1 or 1-DAY ACUVUE TruEye sphere lenses. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator. Eye injury or surgery within 12 weeks immediately prior to enrollment. History of herpetic keratitis, ocular surgery or irregular cornea. Prior refractive surgery. Monocular (only 1 eye with functional vision) or fit with only 1 lens. Participation in any clinical trial within 30 days of the enrollment visit. Other protocol-specified exclusion criteria may apply.
Target sample size	100

Research contact person
Name of lead principal investigator	Motozumi Itoi
Organization	Dogenzaka Itoi Eye Clinic
Division name	Dogenzaka Itoi Eye Clinic
Address	1-10-19 Dogenzaka Shibuya-ku, Tokyo
TEL	03-5784-4616
Email	itoi@eyeacademy.net

Public contact
Name of contact person	Mitsugu Watanabe
Organization	Alcon Japan Ltd.
Division name	Phase IV, Clinical & Regulatory Affairs Division Medical Affairs
Address	1-23-1 Toranomon, Minato-ku, Tokyo
TEL	03-6899-5054
Homepage URL
Email	mitsugu.watanabe@alcon.com

Sponsor
Institute	Alcon Japan Ltd.
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)

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	2016 Year 04 Month 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 02 Month 19 Day
Anticipated trial start date	2016 Year 04 Month 25 Day
Last follow-up date	2016 Year 09 Month 14 Day
Date of closure to data entry	2016 Year 09 Month 23 Day
Date trial data considered complete	2016 Year 10 Month 04 Day
Date analysis concluded	2016 Year 10 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 19 Day
Last modified on	2018 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025333