MyopiaNCT06098339

Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

A study testing Lens A (fanfilcon A) and Lens B (lotrafilcon B) in people with Myopia and Hyperopia, run by CooperVision, Inc. at 3 sites in 2 countries.

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 purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers. Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Myopia, Hyperopia
What is being tested?: Lens A (fanfilcon A) and Lens B (lotrafilcon B)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 3 sitesin 2 countries
Study dates: 13 Nov 2023to 4 Apr 2024
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 18 to 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
Had read and signed an information consent letter;
Were willing and able to follow instructions and maintain the appointment schedule;
Self-reported having had a full eye examination in the previous two years;
Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;

Show all 11Show fewer

Habitually wore spherical soft contact lenses, for the past 3 months minimum:
It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;
For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
Had refractive astigmatism no higher than -0.75DC in each eye;
Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Who cannot join

Were 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 or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
Had known sensitivity to the diagnostic sodium fluorescein used in the study;
Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
Had undergone refractive error surgery or intraocular surgery.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Coan Eye Care
Ocoee, Florida, 34761
Nittany Eye Associates
State College, Pennsylvania, 16801

Other trials in United States

Canada1 site

Insight Eye Care
Waterloo, Ontario, N2L 3S1

Other trials in Canada

About this study

The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Read the detailed description

This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.

Conditions: Myopia, Hyperopia
Being tested: Lens A (fanfilcon A), Lens B (lotrafilcon B)
Medical subject headings: Myopia, Hyperopia

What participants receive

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

Lens A (fanfilcon A)Device
Daily wear for one month
Lens B (lotrafilcon B)Device
Daily wear for one month

Study groups in NCT06098339
Study group	Role	What they receive
Lens A, then Lens B	Experimental	Participants wore Lens A for one month and then Lens B for one month. Receives: Device: Lens A (fanfilcon A); Device: Lens B (lotrafilcon B)
Lens B, then Lens A	Experimental	Participants wore Lens B one month and then Lens A for one month. Receives: Device: Lens A (fanfilcon A); Device: Lens B (lotrafilcon B)

What is being measured

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

Lens Handling on Removal
Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.
Measured: Day 27

Timeline

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

13 Nov 20234 Apr 2024

First posted24 Oct 2023
Study start13 Nov 2023
Primary completion4 Apr 2024
Study completion4 Apr 2024

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 MyopiaStudies 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: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06098339
Sponsor's protocol ID: EX-MKTG-151
Status last verified: May 2024
First submitted: 19 Oct 2023
Last updated: 28 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
ClinicalTrials.gov ID: NCT06098339
Acronym / sponsor ID: EX-MKTG-151
Conditions: Myopia, Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Collaborators: Centre for Ocular Research & Education, Canada
Study start: 13 Nov 2023 (actual)
Primary completion: 4 Apr 2024 (actual)
Study completion: 4 Apr 2024 (actual)
First posted: 24 Oct 2023 (actual)
Results: Posted 9 Jul 2024

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 was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lens A, then Lens B	Experimental	Device: Lens A (fanfilcon A), Device: Lens B (lotrafilcon B)Participants wore Lens A for one month and then Lens B for one month.
Lens B, then Lens A	Experimental	Device: Lens A (fanfilcon A), Device: Lens B (lotrafilcon B)Participants wore Lens B one month and then Lens A for one month.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
Had read and signed an information consent letter;
Were willing and able to follow instructions and maintain the appointment schedule;
Self-reported having had a full eye examination in the previous two years;
Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;

Key exclusion criteria (7 listed)

Were 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 or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
Had known sensitivity to the diagnostic sodium fluorescein 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
Lens A (fanfilcon A)Daily wear for one month	Device	Lens A, then Lens B, Lens B, then Lens A
Lens B (lotrafilcon B)Daily wear for one month	Device	Lens A, then Lens B, Lens B, then Lens A

Primary outcome

Lens Handling on Removal
Time frame: Day 27
Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.

Results and safety

Results posted to the registry on 9 Jul 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
Lens A, Then Lens B	25	24
Lens B, Then Lens A	28	26

Primary outcome: Lens Handling on Removal

Time frame: Day 27. Mean (Standard Deviation). Unit: score on a scale

Measure	Lens A n = 49	Lens B n = 49
Value	84 (21)	89 (17)

Population analysed: Analysis population includes all participants that were eligible (inclusion/exclusion criteria) and completed all study visits. Of 50 participants that completed the study, 1 was removed from the analysis due to a symptomatic adverse event at the final study visit which may have impacted the study data.

Adverse events

Time frame: The duration of the clinical trial, approximately 2-3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lens A	0 of 50 (0%)	5 of 50 (10%)	0 of 50
Lens B	0 of 50 (0%)	4 of 50 (8%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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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.

Carolyn MacNeil principal investigator

Insight Eye Care

Abigail Gillogly-Harsch principal investigator

Nittany Eye Associates

Roxanne Achong-Coan principal investigator

Coan Eye Care

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lens A (fanfilcon A) and Lens B (lotrafilcon B) in people with Myopia and Hyperopia, run by CooperVision, Inc. at 3 sites in 2 countries.

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 11 inclusion and 7 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 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, 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?

Yes. Results are posted in the registry (first posted 9 Jul 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?

Lens Handling on Removal (time frame: Day 27). 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 NCT06098339.

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 28 Aug 2024.