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

NCT06369987 | Completed FDA Device

• 1 other identifier: 46238
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

• High contrast visual acuity (logMAR) at 6m

  High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 6m

  Day 1

• High contrast visual acuity (logMAR) at 40cm

  High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 40cm

  Day 1

Study Arms (2)

Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal

EXPERIMENTAL

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

Device: Deleficon A (multifocal); Device: Senofilcon A (multifocal)

ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal

EXPERIMENTAL

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

Device: Deleficon A (multifocal); Device: Senofilcon A (multifocal)

Interventions

Deleficon A (multifocal) DEVICE

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

Also known as: Dailies Total1 Multifocal

ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal; Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal

Senofilcon A (multifocal) DEVICE

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

Also known as: ACUVUE OASYS MAX 1-DAY Multifocal

ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal; Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal

Eligibility Criteria

• Age: 42 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 42 years of age and has full legal capacity to volunteer;
• Have signed an information consent letter;
• Are willing and able to follow instructions and maintain the appointment schedule;
• Habitually wears soft contact lenses for the past 3 months (minimum);
• Are presbyopic and require a reading addition of at least +0.75D and no more than +1.75D;
• Can be refracted and achieve monocular spectacle distance vision of at least 20/25 Snellen (or +0.10logMAR) visual acuity;
• 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);
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

Centre for Ocular Research & Education (CORE)

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Lyndon Jones, PhD, FCOptom

  Centre for Ocular Research & Education (CORE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: April 25, 2024
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)