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

December 4, 2024 updated by: University of Waterloo
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 1
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Waterloo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education (CORE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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