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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030247
Receipt No. R000034374
Scientific Title Clinical Evaluation of DAILIES TOTAL 1 Multifocal Compared to 1-Day Acuvue Moist Multifocal in a Japanese Population
Date of disclosure of the study information 2017/12/04
Last modified on 2018/10/30

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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
Middle name
Last name Kenichi Yoshino
Organization Yoshino Eye Clinic
Division name Yoshino Eye Clinic
Zip code
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
Middle name
Last name Mitsugu Watanabe
Organization Alcon Japan Ltd.
Division name Medical Affairs, Clinical & Regulatory Affairs Division
Zip code
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
Address
Tel
Email

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 Completed
Date of protocol fixation
2017 Year 09 Month 21 Day
Date of IRB
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
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=R000034374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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