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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Deleficon A (multifocal); Device: Senofilcon A (multifocal)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education (CORE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Deleficon A (multifocal); Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia.; Other Names: Dailies Total1 Multifocal; Device: Senofilcon A (multifocal); Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia; Other Names: ACUVUE OASYS MAX 1-DAY Multifocal
Experimental: 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.	Device: Deleficon A (multifocal); Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia.; Other Names: Dailies Total1 Multifocal; Device: Senofilcon A (multifocal); Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia; Other Names: ACUVUE OASYS MAX 1-DAY Multifocal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education (CORE)

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Actual): November 21, 2024
• Study Completion (Actual): November 21, 2024

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 46238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes