MyopiaNCT05313412

Clinical Evaluation of Two Silicone Hydrogel Contact Lenses

A study testing Lens A (comfilcon A lens) and Lens B (lehfilcon A lens) 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

This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
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: 38 participants
Where: 1 siteUnited Kingdom
Study dates: 27 Jan 2022to 21 Apr 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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

They are aged between 18 and 40 years.
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 have successfully worn contact lenses within six months of starting the study.
They can be satisfactorily fitted with the study contact lenses.
They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.

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They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.
They own and habitually wear single vision spectacles.
They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.
They agree not to participate in other clinical research while enrolled on this study.

Who cannot join

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

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They are pregnant or breastfeeding.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.
They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research
Manchester

Other trials in United Kingdom

About this study

This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.

Read the detailed description

This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence.

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

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
6 hours
Lens B (lehfilcon A lens)Device
6 hours

Study groups in NCT05313412
Study group	Role	What they receive
Lens A, Then Lens B	Experimental	Participants will wear Lens A for six hours and then cross over to wear Lens B for six hours. 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 six hours and then cross over to wear Lens A for six hours. 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.

Ease of Lens Insertion
Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)
Measured: 6 hours

Timeline

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

27 Jan 202221 Apr 2022

First posted6 Apr 2022
Study start27 Jan 2022
Primary completion21 Apr 2022
Study completion21 Apr 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 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: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05313412
Sponsor's protocol ID: C21-706 (EX-MKTG-127)
Status last verified: Sep 2022
First submitted: 24 Mar 2022
Last updated: 9 May 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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
ClinicalTrials.gov ID: NCT05313412
Acronym / sponsor ID: C21-706 (EX-MKTG-127)
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 27 Jan 2022 (actual)
Primary completion: 21 Apr 2022 (actual)
Study completion: 21 Apr 2022 (actual)
First posted: 6 Apr 2022 (actual)
Results: Posted 9 May 2023

Clinical summary

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

This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.

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

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

They are aged between 18 and 40 years.
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 have successfully worn contact lenses within six months of starting the study.
They can be satisfactorily fitted with the study contact lenses.

Key exclusion criteria (10 listed)

They have an ocular disorder which would normally contraindicate contact lens wear.
They have a systemic disorder which would normally contraindicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
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
Lens A (comfilcon A lens)6 hours	Device	Lens A, Then Lens B, Lens B, Then Lens A
Lens B (lehfilcon A lens)6 hours	Device	Lens A, Then Lens B, Lens B, Then Lens A

Primary outcome

Ease of Lens Insertion
Time frame: 6 hours
Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)

Results and safety

Results posted to the registry on 9 May 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	19	19
Lens B, Then Lens A	19	19

Primary outcome: Ease of Lens Insertion

Time frame: 6 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Lens A n = 38	Lens B n = 38
Value	92.1 (10.3)	90.9 (17.4)

Adverse events

Time frame: From dispense up to six hours on each lens type, for a total of 12 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lens A	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Lens B	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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, PhD,MCOptom 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 Lens A (comfilcon A lens) and Lens B (lehfilcon A lens) 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 10 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 9 May 2023. 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 9 May 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?

Ease of Lens Insertion (time frame: 6 hours). 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 NCT05313412.

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 9 May 2023.