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

NCT ID: NCT03341923

Last Updated: 2019-04-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2018-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractive Error Presbyopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DT1MF, then AMMF

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

Group Type OTHER

Delefilcon A multifocal contact lenses

Intervention Type DEVICE

Silicone hydrogel multifocal contact lenses for daily disposable wear

Etafilcon A multifocal contact lenses

Intervention Type DEVICE

Hydrogel multifocal contact lenses for daily disposable wear

AMMF, then DT1MF

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

Group Type OTHER

Delefilcon A multifocal contact lenses

Intervention Type DEVICE

Silicone hydrogel multifocal contact lenses for daily disposable wear

Etafilcon A multifocal contact lenses

Intervention Type DEVICE

Hydrogel multifocal contact lenses for daily disposable wear

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Delefilcon A multifocal contact lenses

Silicone hydrogel multifocal contact lenses for daily disposable wear

Intervention Type DEVICE

Etafilcon A multifocal contact lenses

Hydrogel multifocal contact lenses for daily disposable wear

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DAILIES TOTAL 1® Multifocal 1-DAY ACUVUE® Moist® Multifocal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alcon Investigative Site

Koto-Ku, Tokyo, Japan

Site Status

Alcon Investigative Site

Nakano-ku, Tokyo, Japan

Site Status

Alcon Investigative Site

Shinagawa-Ku, Tokyo, Japan

Site Status

Alcon Investigative Site

Taitō City, Tokyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLJ369-P001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.