MyopiaNCT04195581

A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems

A study testing comfilcon A and fanfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.

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 clinical performance of the two contact lenses when used in combination with three care systems. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: comfilcon A and fanfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited Kingdom
Study dates: 16 Sep 2019to 7 May 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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

They are aged 18-50 and have capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They are an existing wearer of reusable, single vision, spherical soft contact lenses.
They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)
They have a spectacle cylindrical correction of -1.00D or less in each eye.

Show all 9Show fewer

At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
They agree not to participate in other clinical research for the duration of the study.

Who cannot join

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

Show all 10Show fewer

They are pregnant or breastfeeding.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The University of Manchester
Manchester

Other trials in United Kingdom

About this study

The objective of the study was to compare the clinical performance of the two contact lenses when used in combination with three care systems.

Read the detailed description

This was a randomized, open-label, crossover study, controlled by cross-comparison. Subjects were randomized to wear each lens and solution combination for a month in random sequence; that is for a total of six months.

Conditions: Myopia
Being tested: comfilcon A, fanfilcon A
Medical subject headings: Myopia

What participants receive

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

comfilcon ADevice
Subjects were randomized to wear each lens and solution combination for a month.
fanfilcon ADevice
Subjects were randomized to wear each lens and solution combination for a month.

Study groups in NCT04195581
Study group	Role	What they receive
comfilcon A with Hy-Care Multi-purpose solution	Experimental	Subjects were randomized to wear each lens and solution combination for a month. Receives: Device: comfilcon A
comfilcon A with All in One Light Multi-purpose solution	Experimental	Subjects were randomized to wear each lens and solution combination for a month. Receives: Device: comfilcon A
comfilcon A with Refine One Step Hydrogen Peroxide Solution	Experimental	Subjects were randomized to wear each lens and solution combination for a month. Receives: Device: comfilcon A
fanfilcon A with Hy-Care Multi-purpose solution	Active comparator	Subjects were randomized to wear each lens and solution combination for a month. Receives: Device: fanfilcon A
fanfilcon A with All in One Light multi-purpose solution	Active comparator	Subjects were randomized to wear each lens and solution combination for a month. Receives: Device: fanfilcon A
fanfilcon A with Refine One Step Hydrogen Peroxide Solution	Active comparator	Subjects were randomized to wear each lens and solution combination for a month. Receives: Device: fanfilcon A

What is being measured

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

Overall Comfort
Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Measured: One Month
Comfort on Insertion
Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Measured: One Month
Comfort Before Removal
Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Measured: One Month

Secondary outcomes (8)

Vision
Vision will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)
Measured: One Month
Variable Vision
Variable Vision will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of variation in vision, 20 - Very poor. Excessive variation in vision which definitely affects wearing my contact lenses, 40 - Poor. A level of variation in vision which is sometimes annoying, Good. Acceptable level of variation in vision, 80 - Very good. Very occasional or very slight sensation of variation in vision, 100 - Excellent. No variation in vision).
Measured: One Month
Vision at Night
Vision at night will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)
Measured: One Month
Dryness
Dryness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of dryness, 20 - Very poor. Dryness which definitely affects wearing my contact lenses, 40 - Poor. A level of dryness which is sometimes annoying, 60 - Good. Acceptable level of dryness, 80 - Very good. Very occasional or very slight sensation of dryness only, 100 - Excellent. I have no sensation of dryness whatsoever).
Measured: One Month
Ocular Redness
Ocular Redness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of redness, 20 - Very poor. Excessive redness which definitely affects wearing my contact lenses, 40 - Poor. A level of redness which is sometimes annoying, 60 - Good. Acceptable level of redness, 80 - Very good. Very occasional or very slight awareness of redness, 100 - Excellent. No redness).
Measured: One Month
Burning/Stinging
Burning/Stinging will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of burning or stinging, 20 - Very poor. Excessive burning or stinging which definitely affects wearing my contact lenses, 40 - Poor. A level of burning or stinging which is sometimes annoying, 60 - Good. Acceptable level of burning or stinging, 80 - Very good. Very occasional or very slight sensation of burning or stinging, 100 - Excellent. No burning or stinging).
Measured: One Month
Ease of Lens Insertion
Ease of lens insertion will be assessed using vertical visual analogue scales 0-100. (0 - Unmanageable. Lenses impossible to insert, 20 - Very poor. Difficult and occasional unsuccessful insertion, 40 - Poor. Difficult with very occasional unsuccessful insertion, 60 - Good. Some problems but lens insertion usually successful, 80 - Very good. Occasional difficulty with lens insertion, 100 - Excellent. No problems with lens insertion).
Measured: One Month
Ease of Lens Removal
Ease of lens removal will be assessed using vertical visual analogue scales (0-100) ( 0 - Unmanageable. Lenses impossible to remove, 20 - Very poor. Difficult and occasional unsuccessful removal, 40 - Poor. Difficult with very occasional unsuccessful removal, 60 - Good. Some problems but lens removal usually successful, 80 - Very good. Occasional difficulty with lens removal, 100 - Excellent. No problems with lens removal).
Measured: One Month

Timeline

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

16 Sep 20197 May 2020

First posted12 Dec 2019
Study start16 Sep 2019
Primary completion7 May 2020
Study completion7 May 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 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
Model description: Subjects will use each lens and solution combination for a month in random sequence for a total of six months.
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04195581
Sponsor's protocol ID: C19-658 EX-MKTG-108
Status last verified: May 2021
First submitted: 10 Dec 2019
Last updated: 11 Jun 2021
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 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
ClinicalTrials.gov ID: NCT04195581
Acronym / sponsor ID: C19-658 EX-MKTG-108
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 16 Sep 2019 (actual)
Primary completion: 7 May 2020 (actual)
Study completion: 7 May 2020 (actual)
First posted: 12 Dec 2019 (actual)
Results: Posted 11 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 clinical performance of the two contact lenses when used in combination with three care systems.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: Subjects will use each lens and solution combination for a month in random sequence for a total of six months.

Arm	Type	Receives
comfilcon A with Hy-Care Multi-purpose solution	Experimental	Device: comfilcon ASubjects were randomized to wear each lens and solution combination for a month.
comfilcon A with All in One Light Multi-purpose solution	Experimental	Device: comfilcon ASubjects were randomized to wear each lens and solution combination for a month.
comfilcon A with Refine One Step Hydrogen Peroxide Solution	Experimental	Device: comfilcon ASubjects were randomized to wear each lens and solution combination for a month.
fanfilcon A with Hy-Care Multi-purpose solution	Active comparator	Device: fanfilcon ASubjects were randomized to wear each lens and solution combination for a month.
fanfilcon A with All in One Light multi-purpose solution	Active comparator	Device: fanfilcon ASubjects were randomized to wear each lens and solution combination for a month.
fanfilcon A with Refine One Step Hydrogen Peroxide Solution	Active comparator	Device: fanfilcon ASubjects were randomized to wear each lens and solution combination for a month.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

They are aged 18-50 and have capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They are an existing wearer of reusable, single vision, spherical soft contact lenses.
They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)

Key exclusion criteria (10 listed)

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.

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
comfilcon ASubjects were randomized to wear each lens and solution combination for a month.	Device	comfilcon A with All in One Light Multi-purpose solution, comfilcon A with Hy-Care Multi-purpose solution, comfilcon A with Refine One Step Hydrogen Peroxide Solution
fanfilcon ASubjects were randomized to wear each lens and solution combination for a month.	Device	fanfilcon A with All in One Light multi-purpose solution, fanfilcon A with Hy-Care Multi-purpose solution, fanfilcon A with Refine One Step Hydrogen Peroxide Solution

Primary outcome

Overall Comfort
Time frame: One Month
Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Comfort on Insertion
Time frame: One Month
Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Comfort Before Removal
Time frame: One Month
Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

8 secondary outcomes

Vision
Time frame: One Month
Variable Vision
Time frame: One Month
Vision at Night
Time frame: One Month
Dryness
Time frame: One Month
Ocular Redness
Time frame: One Month
Burning/Stinging
Time frame: One Month
Ease of Lens Insertion
Time frame: One Month
Ease of Lens Removal
Time frame: One Month

Results and safety

Results posted to the registry on 11 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
All Participants	28	24

Primary outcome: Overall Comfort

Time frame: One Month. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A With All in One Light Multi-purpose Solution n = 24	Comfilcon A With Hy-Care Multi-purpose Solution n = 25	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n = 24	Fanfilcon A With All in One Light Multi-purpose Solution n = 27	Fanfilcon A With Hy-Care Multi-purpose Solution n = 25	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n = 27
Value	86.0 (12.0)	81.6 (14.9)	81.0 (17.1)	87.7 (11.7)	88.0 (9.5)	82.7 (16.7)

Primary outcome: Comfort on Insertion

Time frame: One Month. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A With All in One Light Multi-purpose Solution n = 24	Comfilcon A With Hy-Care Multi-purpose Solution n = 25	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n = 24	Fanfilcon A With All in One Light Multi-purpose Solution n = 27	Fanfilcon A With Hy-Care Multi-purpose Solution n = 25	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n = 27
Value	88.3 (12.7)	85.8 (15.0)	84.0 (17.1)	88.6 (14.9)	90.3 (10.6)	87.3 (11.8)

Primary outcome: Comfort Before Removal

Time frame: One Month. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A With All in One Light Multi-purpose Solution n = 24	Comfilcon A With Hy-Care Multi-purpose Solution n = 25	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n = 24	Fanfilcon A With All in One Light Multi-purpose Solution n = 27	Fanfilcon A With Hy-Care Multi-purpose Solution n = 25	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n = 27
Value	80.0 (17.2)	72.8 (17.8)	74.2 (19.9)	79.1 (17.2)	82.4 (14.2)	76.1 (19.9)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A With Hy-Care Multi-purpose Solution	1 of 30 (3.3%)	2 of 30 (6.7%)	0 of 30
Comfilcon A With All in One Light Multi-purpose Solution	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Comfilcon A With Refine One Step Hydrogen Peroxide Solution	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Fanfilcon A With Hy-Care Multi-purpose Solution	0 of 28 (0%)	2 of 28 (7.1%)	0 of 28
Fanfilcon A With All in One Light Multi-purpose Solution	1 of 28 (3.6%)	1 of 28 (3.6%)	0 of 28
Fanfilcon A With Refine One Step Hydrogen Peroxide Solution	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

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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.

Philip Morgan, MCOptom FAAO FBCLA principal investigator

Eurolens Research

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

Questions about this trial

What is this clinical trial studying?

A study testing comfilcon A and fanfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.

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 10 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 11 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 1 site in United Kingdom. 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 11 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?

Overall Comfort (time frame: One Month). The study lists 3 primary outcomes in all. 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 NCT04195581.

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 11 Jun 2021.