PresbyopiaNCT05579886

Evaluating Two Multifocal Daily Disposable Contact Lenses

A study testing Test Lens in people with Presbyopia, run by CooperVision, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks. Read more about this study

Who is it for?: Ages 42 years and older
Conditions the study is for: Presbyopia
What is being tested?: Test Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: 10 Oct 2022to 7 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

A person was eligible for inclusion in the study if he/she:
Was at least 42 years of age and had full legal capacity to volunteer;
Had read and signed an information consent letter;
Self-reported having had a full eye examination in the previous two years;
Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Was willing and able to follow instructions and maintain the appointment schedule;

Show all 10Show fewer

Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);
Had refractive astigmatism no higher than -0.75DC in each eye;
Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)

Who cannot join

A person was excluded from the study if he/she:
Was participating in any concurrent clinical or research study;
Had any known active ocular disease and/or infection that contraindicated contact lens wear;
Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
Was using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
Had undergone refractive error surgery or interocular surgery.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

ProCare Vision Center
Granville, Ohio, 43023
Coan Eye Care & Optical Boutique
Ocoee, Florida, 34761
Kannarr Eye Care
Pittsburg, Kansas, 66762
Nittany Eye Associates
State College, Pennsylvania, 16801
Sacco Eye Group
Vestal, New York, 13850

Other trials in United States

About this study

Official title: Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design

Read the detailed description

This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.

Conditions: Presbyopia
Being tested: Control Lens, Test Lens
Medical subject headings: Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control LensDevice
Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks
Test LensDevice
Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks

Study groups in NCT05579886
Study group	Role	What they receive
Control Lens	Active comparator	All participants wore the Control Lens for 2 weeks (Period 1) Receives: Device: Control Lens
Test Lens	Experimental	All participants wore the Test Lens for 2 weeks (Period 2) Receives: Device: Test Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Comfort Just After Lens Insertion
Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 20227 Feb 2023

First posted14 Oct 2022
Study start10 Oct 2022
Primary completion7 Feb 2023
Study completion7 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05579886
Sponsor's protocol ID: EX-MKTG-140
Status last verified: Jan 2024
First submitted: 11 Oct 2022
Last updated: 20 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
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Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design
ClinicalTrials.gov ID: NCT05579886
Acronym / sponsor ID: EX-MKTG-140
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Collaborators: Centre for Ocular Research & Education, Canada
Study start: 10 Oct 2022 (actual)
Primary completion: 7 Feb 2023 (actual)
Study completion: 7 Feb 2023 (actual)
First posted: 14 Oct 2022 (actual)
Results: Posted 20 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Lens	Active comparator	Device: Control LensAll participants wore the Control Lens for 2 weeks (Period 1)
Test Lens	Experimental	Device: Test LensAll participants wore the Test Lens for 2 weeks (Period 2)

Who may qualify

Ages: 42 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Was at least 42 years of age and had full legal capacity to volunteer;
Had read and signed an information consent letter;
Self-reported having had a full eye examination in the previous two years;
Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Was willing and able to follow instructions and maintain the appointment schedule;

Key exclusion criteria (8 listed)

Was participating in any concurrent clinical or research study;
Had any known active ocular disease and/or infection that contraindicated contact lens wear;
Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
Was using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;

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
Control LensDaily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks	Device	Control Lens
Test LensDaily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks	Device	Test Lens

Primary outcome

Comfort Just After Lens Insertion
Time frame: 2 weeks
Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.

Results and safety

Results posted to the registry on 20 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Lens (2ADD)	60	60
Test Lens (3ADD)	0	0

Primary outcome: Comfort Just After Lens Insertion

Time frame: 2 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Lens (2ADD) n = 60	Test Lens (3ADD) n = 60
Value	9.1 (1.4)	9.2 (1.1)

Population analysed: All participants wore Control Lens and Test Lens in sequential order.

Adverse events

Time frame: From dispense to study exit, approximately 6-8 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Lens (2ADD)	0 of 60 (0%)	1 of 60 (1.7%)	0 of 60
Test Lens (3ADD)	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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.

Andrew Sacco principal investigator

Sacco Eye Group

Shane Kannarr principal investigator

Kannarr Eye Care

Katherine Bickle principal investigator

ProCare Vision Center

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Lens in people with Presbyopia, run by CooperVision, Inc. at 5 sites in United States.

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 10 inclusion and 8 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comfort Just After Lens Insertion (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05579886.

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 20 Feb 2024.