AmetropiaNCT05166902

Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

A study testing Lens A (comfilcon A lens) and Lens B (lehfilcon A lens) in people with Ametropia, run by CooperVision, Inc. at 4 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

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Ametropia
What is being tested?: Lens A (comfilcon A lens) and Lens B (lehfilcon A lens)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 4 sitesin 2 countries
Study dates: 31 Jan 2022to 9 Jul 2022
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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Self-reports having a full eye examination in the previous two years;
Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;

Show all 10Show fewer

Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: The habitual contact lens brand was restricted such that no more than one third were to be Biofinity Energys brand (or their equivalent private label brand name) and no more than one third were to be Alcon brand);
Has refractive astigmatism no higher than -0.75DC in each eye;
Can 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

Is participating in any concurrent clinical or research study;
Has any known active ocular disease and/or infection that contraindicates contact lens wear;
Has a systemic or ocular 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

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States2 sites

Coan Eye Care
Ocoee, Florida, 34761
Nittany Eye Associate
State College, Pennsylvania, 168801

Other trials in United States

Canada2 sites

Eyes on Sheppard Clinic
Toronto, Ontario, M2N 3A4
Spadina Optometry
Toronto, Ontario, M5V 3E7

Other trials in Canada

About this study

Official title: Evaluation of Monthly Replacement Lens Designs in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.

Read the detailed description

This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.

Conditions: Ametropia
Being tested: Lens A (comfilcon A lens), Lens B (lehfilcon A lens)
Medical subject headings: Refractive Errors

What participants receive

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

Lens A (comfilcon A lens)Device
1 month
Lens B (lehfilcon A lens)Device
1 month

Study groups in NCT05166902
Study group	Role	What they receive
Lens A, Then Lens B	Experimental	Participants will wear lens A for one month and then cross over to wear lens B for one month. Receives: Device: Lens A (comfilcon A lens); Device: Lens B (lehfilcon A lens)
Lens B, Then Lens A	Experimental	Participants will wear lens B for one month and then cross over to wear lens A for one month. Receives: Device: Lens A (comfilcon A lens); Device: Lens B (lehfilcon A lens)

What is being measured

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

Subjective Ratings on Lens Handling on Removal
Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)
Measured: Day 27

Timeline

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

31 Jan 20229 Jul 2022

First posted22 Dec 2021
Study start31 Jan 2022
Primary completion9 Jul 2022
Study completion9 Jul 2022

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 AmetropiaStudies 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: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05166902
Sponsor's protocol ID: EX-MKTG-130
Status last verified: May 2022
First submitted: 8 Dec 2021
Last updated: 27 Jul 2023
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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Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
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The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
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Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
Refractive Ametropia

All Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Monthly Replacement Lens Designs in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
ClinicalTrials.gov ID: NCT05166902
Acronym / sponsor ID: EX-MKTG-130
Conditions: Ametropia
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Collaborators: Centre for Ocular Research & Education, Canada
Study start: 31 Jan 2022 (actual)
Primary completion: 9 Jul 2022 (actual)
Study completion: 9 Jul 2022 (actual)
First posted: 22 Dec 2021 (actual)
Results: Posted 27 Jul 2023

Clinical summary

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

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.

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 (comfilcon A lens), Device: Lens B (lehfilcon A lens)Participants will wear lens A for one month and then cross over to wear lens B for one month.
Lens B, Then Lens A	Experimental	Device: Lens A (comfilcon A lens), Device: Lens B (lehfilcon A lens)Participants will wear lens B for one month and then cross over to wear lens A for one month.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Self-reports having a full eye examination in the previous two years;
Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;

Key exclusion criteria (7 listed)

Is participating in any concurrent clinical or research study;
Has any known active ocular disease and/or infection that contraindicates contact lens wear;
Has a systemic or ocular 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;

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 (comfilcon A lens)1 month	Device	Lens A, Then Lens B, Lens B, Then Lens A
Lens B (lehfilcon A lens)1 month	Device	Lens A, Then Lens B, Lens B, Then Lens A

Primary outcome

Subjective Ratings on Lens Handling on Removal
Time frame: Day 27
Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)

Results and safety

Results posted to the registry on 27 Jul 2023, 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	34	34
Lens B, Then Lens A	33	32

Primary outcome: Subjective Ratings on Lens Handling on Removal

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

Measure	Lens A n = 66	Lens B n = 66
Value	8.3 (1.8)	8.8 (1.2)

Population analysed: Participants

Adverse events

Time frame: From dispense up to one month on each study lens, for total of two months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lens A	0 of 66 (0%)	4 of 66 (6.1%)	0 of 66
Lens B	0 of 66 (0%)	2 of 66 (3%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ametropia

Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
Myopia, Refractive Ametropia
Recruiting
The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
Myopia, Refractive Ametropia
Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
Myopia, Refractive Ametropia
Recruiting
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
Refractive Ametropia

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.

David Wilkinson principal investigator

Spadina Optometry

Roxanne Achong-Coan principal investigator

Coan Eyecare

Fiona Soong principal investigator

Eyes on Sheppard Clinic

4 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 (comfilcon A lens) and Lens B (lehfilcon A lens) in people with Ametropia, run by CooperVision, Inc. at 4 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 10 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 27 Jul 2023). 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 Ratings on 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 NCT05166902.

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 27 Jul 2023.