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

NCT03341923 | Completed Results FDA Device

• 1 other identifier: CLJ369-P001
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 4

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.

Conditions

Refractive Error; Presbyopia

Keywords

contact lenses; lens centration; multifocal

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"

  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.

  Day 14, each product

Study Arms (2)

DT1MF, then AMMF

OTHER

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

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

AMMF, then DT1MF

OTHER

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

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

Interventions

Delefilcon A multifocal contact lenses DEVICE

Silicone hydrogel multifocal contact lenses for daily disposable wear

Also known as: DAILIES TOTAL 1® Multifocal

AMMF, then DT1MF; DT1MF, then AMMF

Etafilcon A multifocal contact lenses DEVICE

Hydrogel multifocal contact lenses for daily disposable wear

Also known as: 1-DAY ACUVUE® Moist® Multifocal

AMMF, then DT1MF; DT1MF, then AMMF

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Alcon Investigative Site

Koto-Ku, Tokyo, 136-0071, Japan

Location

Alcon Investigative Site

Nakano-ku, Tokyo, 164-0001, Japan

Location

Alcon Investigative Site

Shinagawa-Ku, Tokyo, 141-0021, Japan

Location

Alcon Investigative Site

Taitō City, Tokyo, 110-0005, Japan

Location

MeSH Terms

Conditions

Refractive Errors; Presbyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Group Manager, Vision Care
• Organization: Alcon Japan, Ltd.

alcon.medinfo@alcon.com

+81.3.6899.5061

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 14, 2017
• Study Start: December 20, 2017
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)