PresbyopiaNCT04449263

Comparing the Performance of 1 Day Multifocal Contact Lenses

A study testing Lens A, Lens B and Habitual Lenses 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.

Official record

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Trial summary

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. 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?: Lens A, Lens B and Habitual Lenses
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: 27 Jul 2020to 30 Dec 2020
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is at least 42 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears multifocal soft contact lenses, for the past 3 months minimum;

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Has refractive astigmatism no higher than -0.75DC;
Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

Who cannot join

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact lenses;
Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
Has known sensitivity to the diagnostic sodium fluorescein used in the study;
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
Has undergone refractive error surgery or intraocular 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
Kannarr Eye Care
Pittsburg, Kansas, 66762
Scripps Poway Eyecare
San Diego, California, 92131
Golden Vision
Sarasota, Florida, 34237
Golden Optometric Group
Whittier, California, 90606

Other trials in United States

About this study

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Read the detailed description

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Conditions: Presbyopia
Being tested: Lens A, Lens B, Habitual Lenses
Medical subject headings: Presbyopia

What participants receive

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

Lens ADevice
Also called FDA Approved, non-marketed, daily disposable multifocal lens
Subjects will be randomized to wear Lens A (test) for 2 weeks.
Lens BDevice
Also called FDA Approved, daily disposable multifocal lens
Subjects will be randomized to wear Lens B (control) for 2 weeks.
Habitual LensesDevice
All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Study groups in NCT04449263
Study group	Role	What they receive
Lens A (Test)	Experimental	Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study. Receives: Device: Lens A; Device: Lens B; Device: Habitual Lenses
Lens B (Control)	Active comparator	Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study. Receives: Device: Lens A; Device: Lens B; Device: Habitual Lenses
Habitual Lenses	Active comparator	All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B. Receives: Device: Habitual Lenses

What is being measured

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

Subjective At-home Ratings for Ease of Lens Handling for Insertion
Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)
Measured: Day 13

Timeline

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

27 Jul 202030 Dec 2020

First posted26 Jun 2020
Study start27 Jul 2020
Primary completion7 Dec 2020
Study completion30 Dec 2020

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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04449263
Sponsor's protocol ID: EX-MKTG-109
Status last verified: Jun 2021
First submitted: 24 Jun 2020
Last updated: 22 Jun 2021
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

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Clinical Trial With Artiflex Presbyopic (Artiplus)
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VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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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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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing the Performance of 1 Day Multifocal Contact Lenses
ClinicalTrials.gov ID: NCT04449263
Acronym / sponsor ID: EX-MKTG-109
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 27 Jul 2020 (actual)
Primary completion: 7 Dec 2020 (actual)
Study completion: 30 Dec 2020 (actual)
First posted: 26 Jun 2020 (actual)
Results: Posted 21 Jun 2021

Clinical summary

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

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Lens A (Test)	Experimental	Device: Lens A, Device: Lens B, Device: Habitual LensesSubjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.
Lens B (Control)	Active comparator	Device: Lens A, Device: Lens B, Device: Habitual LensesSubjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.
Habitual Lenses	Active comparator	Device: Habitual LensesAll subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.

Who may qualify

Ages: 42 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (8 listed)

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact lenses;
Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or 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
Lens AAlso: FDA Approved, non-marketed, daily disposable multifocal lensSubjects will be randomized to wear Lens A (test) for 2 weeks.	Device	Lens A (Test), Lens B (Control)
Lens BAlso: FDA Approved, daily disposable multifocal lensSubjects will be randomized to wear Lens B (control) for 2 weeks.	Device	Lens A (Test), Lens B (Control)
Habitual LensesAll Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.	Device	Habitual Lenses, Lens A (Test), Lens B (Control)

Primary outcome

Subjective At-home Ratings for Ease of Lens Handling for Insertion
Time frame: Day 13
Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)

Results and safety

Results posted to the registry on 21 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lens A (Test) Then Lens B (Control)	29	29
Lens B (Control) Then Lens A (Test)	30	30

Primary outcome: Subjective At-home Ratings for Ease of Lens Handling for Insertion

Time frame: Day 13. Mean (Standard Deviation). Unit: units on a scale

Measure	Subjects Habitual Lenses n = 58	Lens A (Test) n = 58	Lens B (Control) n = 57
Value	8.90 (1.59)	8.28 (2.10)	9.18 (1.12)

Population analysed: One subject was not included in the analysis for all study arms because of protocol deviation. One more subject was excluded form the analysis from Len B control Arm only.

Adverse events

Time frame: All subjects wore their habitual lenses for two weeks and then randomized to wear test lens A and control lens B for 2 weeks, a total of 6 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Habitual Lenses	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Lens A (Test)	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Lens B (Control)	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Presbyopia

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

Wayne Golden principal investigator

Golden Vision

Keith Wan principal investigator

Scripps Poway Eyecare

Shane Kannarr principal investigator

Kannarr Eye Care

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

Questions about this trial

What is this clinical trial studying?

A study testing Lens A, Lens B and Habitual Lenses 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 9 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 22 Jun 2021. 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 21 Jun 2021). 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?

Subjective At-home Ratings for Ease of Lens Handling for Insertion (time frame: Day 13). 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 NCT04449263.

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 22 Jun 2021.