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

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Deleficon A (multifocal); Device: Senofilcon A (multifocal)

• Registration Number: NCT06369987
• Lead Sponsor: University of Waterloo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Study Start: 2024-04-25
• Primary Completion: 2024-11-21
• Study Completion: 2024-11-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal	Deleficon A (multifocal)	Fit participant with Dailies Total1 Multifocal first, and with ACUVUE OASYS MAX 1-Day Multifocal second.
Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal	Senofilcon A (multifocal)	Fit participant with Dailies Total1 Multifocal first, and with ACUVUE OASYS MAX 1-Day Multifocal second.
ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal	Senofilcon A (multifocal)	Fit participant with ACUVUE OASYS MAX 1-Day Multifocal first, and with Dailies Total1 Multifocal second.
ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal	Deleficon A (multifocal)	Fit participant with ACUVUE OASYS MAX 1-Day Multifocal first, and with Dailies Total1 Multifocal second.

Primary Outcome Measures

Name	Time	Method
High contrast visual acuity (logMAR) at 40cm	Day 1	High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 40cm
High contrast visual acuity (logMAR) at 6m	Day 1	High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 6m

Trial Locations

Locations (1)

Centre for Ocular Research & Education (CORE); 🇨🇦 Waterloo, Ontario, Canada