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OpenTrials
Completed

NCT Number: NCT06369987

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

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.

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Key information

Age range

42 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research & Education (CORE)

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Deleficon A (multifocal)

Device

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

Other names: Dailies Total1 Multifocal

Senofilcon A (multifocal)

Device

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

Other names: ACUVUE OASYS MAX 1-DAY Multifocal

Primary outcomes

  1. High contrast visual acuity (logMAR) at 6m

    Time frame: Day 1

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

  2. High contrast visual acuity (logMAR) at 40cm

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Acronym: GIRAFFE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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