PresbyopiaGIRAFFENCT06369987
Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers
A study testing Deleficon A (multifocal) and Senofilcon A (multifocal) in people with Presbyopia, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Deleficon A (multifocal) and Senofilcon A (multifocal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2024to 21 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Ocular Research & Education (CORE)
Waterloo, Ontario, N2L 3G1
About this study
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.
- Conditions
- Presbyopia
- Being tested
- Deleficon A (multifocal), Senofilcon A (multifocal)
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deleficon A (multifocal)Device
Also called Dailies Total1 Multifocal
Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia.
Senofilcon A (multifocal)Device
Also called ACUVUE OASYS MAX 1-DAY Multifocal
Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia
| Study group | Role | What they receive |
|---|---|---|
| Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal | Experimental | Fit participant with Dailies Total1 Multifocal first, and with ACUVUE OASYS MAX 1-Day Multifocal second. Receives: Device: Deleficon A (multifocal); Device: Senofilcon A (multifocal) |
| ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal | Experimental | Fit participant with ACUVUE OASYS MAX 1-Day Multifocal first, and with Dailies Total1 Multifocal second. Receives: Device: Deleficon A (multifocal); Device: Senofilcon A (multifocal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
High contrast visual acuity (logMAR) at 6m
High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 6m
Measured: Day 1
High contrast visual acuity (logMAR) at 40cm
High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 40cm
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start25 Apr 2024
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, FCOptom, Principal investigator, Centre for Ocular Research & Education (CORE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369987
- Sponsor's protocol ID
- 46238
- Acronym
- GIRAFFE
- Status last verified
- Dec 2024
- First submitted
- 12 Apr 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers
- ClinicalTrials.gov ID
- NCT06369987
- Acronym / sponsor ID
- GIRAFFE / 46238
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal | Experimental | Device: Deleficon A (multifocal), Device: 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 | Experimental | Device: Deleficon A (multifocal), Device: Senofilcon A (multifocal)Fit participant with ACUVUE OASYS MAX 1-Day Multifocal first, and with Dailies Total1 Multifocal second. |
Who may qualify
- Ages
- 42 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deleficon A (multifocal)Also: Dailies Total1 MultifocalDaily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia. | Device | ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal, Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal |
| Senofilcon A (multifocal)Also: ACUVUE OASYS MAX 1-DAY MultifocalDaily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia | Device | ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal, Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon Jones, PhD, FCOptom principal investigator
Centre for Ocular Research & Education (CORE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deleficon A (multifocal) and Senofilcon A (multifocal) in people with Presbyopia, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High contrast visual acuity (logMAR) at 6m (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.