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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021976
Receipt No. R000025333
Scientific Title Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.
Date of disclosure of the study information 2016/04/20
Last modified on 2018/10/30

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Basic information
Public title Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.
Acronym Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.
Scientific Title Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.
Scientific Title:Acronym 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
1st name
Middle name
Last name Motozumi Itoi
Organization Dogenzaka Itoi Eye Clinic
Division name Dogenzaka Itoi Eye Clinic
Zip code
Address 1-10-19 Dogenzaka Shibuya-ku, Tokyo
TEL 03-5784-4616
Email itoi@eyeacademy.net

Public contact
Name of contact person
1st name
Middle name
Last name Mitsugu Watanabe
Organization Alcon Japan Ltd.
Division name Phase IV, Clinical & Regulatory Affairs Division Medical Affairs
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 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

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
2016 Year 02 Month 19 Day
Date of IRB
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

Other
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

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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