UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Evaluation of DAILIES TOTAL 1 Multifocal Compared to 1-Day Acuvue Moist Multifocal in a Japanese Population
Acronym	Clinical Evaluation of DAILIES TOTAL 1 Multifocal Compared to 1-Day Acuvue Moist Multifocal in a Japanese Population
Scientific Title	Clinical Evaluation of DAILIES TOTAL 1 Multifocal Compared to 1-Day Acuvue Moist Multifocal in a Japanese Population
Scientific Title:Acronym	Clinical Evaluation of DAILIES TOTAL 1 Multifocal Compared to 1-Day Acuvue Moist Multifocal in a Japanese Population
Region	Japan

Condition
Condition	Refractive Error Presbyopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this clinical study is to evaluate DAILIES TOTAL1 Multifocal(DT1MF) contact lenses compared to 1-DAY ACUVUE Moist Multifocal(AMMF) contact lenses for investigator-graded lens centration in a Japanese population.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Investigator-graded lens centration of "Optimal" Lens centration will be assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure)
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	DT1MF, then AMMF Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product will be in both eyes for 14 +/- 3 days.
Interventions/Control_2	AMMF, then DT1MF Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product will be worn in both eyes for 14 +/- 3 days.
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-Sign informed consent. -Habitually wear multifocal soft/ silicone hydrogel contact lenses -Require a near spectacle ADD of +0.50D to +2.50D (inclusive) -Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance -Willing to wear contact lenses and attend all study visits -Other protocol-defined inclusion criteria may apply
Key exclusion criteria	-Currently wearing DAILIES TOTAL 1 Multifocal or 1-DAY ACUVUE Moist Multifocal contact lenses -Any eye condition that would make contact lens wear unadvisable -Any use of medication that would make contact lens wear unadvisable -Prior refractive surgery -Other protocol-defined exclusion criteria may apply
Target sample size	134

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Yoshino
Organization	Yoshino Eye Clinic
Division name	Yoshino Eye Clinic
Zip code	110-0005
Address	1-20-10 Ueno, Taito-ku, Tokyo
TEL	03-3839-5092
Email	yoshino.eye.clinic.kenichi@nifty.ne.jp

Public contact
Name of contact person	1st name Mitsugu Middle name Last name Watanabe
Organization	Alcon Japan Ltd.
Division name	Medical Affairs, Clinical & Regulatory Affairs Division
Zip code	105-6333
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)

IRB Contact (For public release)
Organization	MINS IRB
Address	5-20-9-40, Mita, Minato-ku, Tokyo, Japan
Tel	03-6416-1868
Email	npo-mins@j-irb.com

Secondary IDs
Secondary IDs	YES
Study ID_1	NTC03341923
Org. issuing International ID_1	ClinicalTrial.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 04 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	Main results already published
Date of protocol fixation	2017 Year 09 Month 21 Day
Date of IRB	2017 Year 11 Month 17 Day
Anticipated trial start date	2017 Year 12 Month 20 Day
Last follow-up date	2018 Year 06 Month 05 Day
Date of closure to data entry	2018 Year 06 Month 15 Day
Date trial data considered complete	2018 Year 06 Month 29 Day
Date analysis concluded	2018 Year 07 Month 13 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 04 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034374