Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers

NCT ID: NCT06369987

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-25

Study Completion Date

2024-11-21

Brief Summary

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The purpose of this study is to measure the logMAR visual acuity when presbyopic soft lens wearers are fit with Dailies Total1 Multifocal and ACUVUE OASYS MAX 1-DAY Multifocal.

Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal

Fit participant with Dailies Total1 Multifocal first, and with ACUVUE OASYS MAX 1-Day Multifocal second.

Group Type EXPERIMENTAL

Deleficon A (multifocal)

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia.

Senofilcon A (multifocal)

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia

ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal

Fit participant with ACUVUE OASYS MAX 1-Day Multifocal first, and with Dailies Total1 Multifocal second.

Group Type EXPERIMENTAL

Deleficon A (multifocal)

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia.

Senofilcon A (multifocal)

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia

Interventions

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Deleficon A (multifocal)

Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia.

Intervention Type DEVICE

Senofilcon A (multifocal)

Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia

Intervention Type DEVICE

Other Intervention Names

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Dailies Total1 Multifocal ACUVUE OASYS MAX 1-DAY Multifocal

Eligibility Criteria

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Inclusion Criteria

1. Are at least 42 years of age and has full legal capacity to volunteer;
2. Have signed an information consent letter;
3. Are willing and able to follow instructions and maintain the appointment schedule;
4. Habitually wears soft contact lenses for the past 3 months (minimum);
5. Are presbyopic and require a reading addition of at least +0.75D and no more than +1.75D;
6. Can be refracted and achieve monocular spectacle distance vision of at least 20/25 Snellen (or +0.10logMAR) visual acuity;
7. Have contact lens power requirements that fall within the available study lens parameters (distance sphere: +6D to -9D; near addition as per each lens design);
8. Can be fit with the initial fitting guidelines provided by the lens manufacturer and use either Low or Medium Add (same add in both eyes).

Exclusion Criteria

1. Are a current habitual wearer of Dailies Total1 Multifocal or ACUVUE OASYS MAX 1-DAY Multifocal;
2. Has refractive astigmatism higher than -0.75DC in either eye;
3. Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
4. Have any known active ocular disease and/or infection;
5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
7. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
8. Have undergone refractive error surgery;
9. Are a member of the Centre for Ocular Research \& Education (CORE) directly involved in the study.
Minimum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

University of Waterloo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyndon Jones, PhD, FCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre for Ocular Research & Education (CORE)

Locations

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Centre for Ocular Research & Education (CORE)

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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46238

Identifier Type: -

Identifier Source: org_study_id