Status:
COMPLETED
Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
Lead Sponsor:
Alcon Research
Conditions:
Refractive Error
Presbyopia
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 centr...
Detailed Description
Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.
Eligibility Criteria
Inclusion
- Sign informed consent
- Habitually wear multifocal soft/ silicone hydrogel contact lenses
- Require a near spectacle ADD of +0.50 diopters (D) 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
Exclusion
- 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
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2018
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03341923
Start Date
December 20 2017
End Date
June 5 2018
Last Update
April 16 2019
Active Locations (4)
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1
Alcon Investigative Site
Koto-Ku, Tokyo, Japan, 136-0071
2
Alcon Investigative Site
Nakano-ku, Tokyo, Japan, 164-0001
3
Alcon Investigative Site
Shinagawa-Ku, Tokyo, Japan, 141-0021
4
Alcon Investigative Site
Taitō City, Tokyo, Japan, 110-0005