Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population

Alcon

Status: Completed

Conditions: Refractive Error; Presbyopia

Treatments: Device: Delefilcon A multifocal contact lenses; Device: Etafilcon A multifocal contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03341923

CLJ369-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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151 participants in 2 patient groups

DT1MF, then AMMF

Other group

Description:

Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.

Treatment:

Device: Etafilcon A multifocal contact lenses

Device: Delefilcon A multifocal contact lenses

AMMF, then DT1MF

Other group

Description:

Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.

Treatment:

Device: Etafilcon A multifocal contact lenses

Device: Delefilcon A multifocal contact lenses