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

Not Applicable

Completed

• Conditions: Refractive Error; Presbyopia
• Interventions: Device: Delefilcon A multifocal contact lenses; Device: Etafilcon A multifocal contact lenses

• Registration Number: NCT03341923
• Lead Sponsor: Alcon Research

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 centration in a Japanese population.

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.

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2017-12-20
• Primary Completion: 2018-06-05
• Study Completion: 2018-06-05
• Status Verified: 2019-03
• Results First Submitted: 2019-03-26
• Results First Submitted QC: 2019-03-26
• Last Update Submitted: 2019-03-26
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AMMF, then DT1MF	Delefilcon A multifocal contact lenses	Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
DT1MF, then AMMF	Delefilcon A multifocal contact lenses	Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
DT1MF, then AMMF	Etafilcon A multifocal contact lenses	Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
AMMF, then DT1MF	Etafilcon A multifocal contact lenses	Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"	Day 14, each product	Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇯🇵 Taitō, Tokyo, Japan