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

University of Waterloo

Status: Completed

Conditions: Presbyopia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06369987

46238

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 42+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal

Experimental group

Description:

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

Treatment:

Device: Deleficon A (multifocal)

Device: Senofilcon A (multifocal)

ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal

Experimental group

Description:

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

Treatment:

Device: Deleficon A (multifocal)

Device: Senofilcon A (multifocal)