UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021976 |
|---|---|
| Receipt number | 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 16:14:56 |
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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
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
mitsugu.watanabe@alcon.com
Sponsor or person
Institute
Alcon Japan Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025333
