UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030247 |
|---|---|
| Receipt number | 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 | 2020/03/04 15:36:36 |
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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 | 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
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
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
MINS IRB
Address
5-20-9-40, Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034374
