MyopiaNCT06251154

Clinical Comparison of Two Soft Contact Lenses

A study testing Lens 1 and Lens 2 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.

Trial summary

This study was designed to gather short-term clinical performance data for 2 soft contact lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Lens 1 and Lens 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited Kingdom
Study dates: 11 Dec 2023to 8 Jan 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects will only be eligible for the study if:
They were of legal age (18) and capacity to volunteer.
They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
They were willing and able to follow the protocol.
They were wearing soft contact lenses, or had done so within the past two years.
They were able to be fitted with the study lenses within the power range available.

Who cannot join

Subjects will not be eligible if:
They had an ocular disorder which would normally contra-indicate contact lens wear.
They had a systemic disorder which would normally contra-indicate contact lens wear.
They were using any topical medication such as eye drops or ointment.
They were aphakic.
They had had corneal refractive surgery.

Show all 10Show fewer

They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
They were pregnant or lactating.
They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
They had taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research
Manchester, M13 9PL

Other trials in United Kingdom

About this study

Official title: A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)

This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

Read the detailed description

The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.

Conditions: Myopia
Being tested: Lens 1, Lens 2
Medical subject headings: Myopia

What participants receive

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

Lens 1Device
Daily disposable silicone hydrogel contact lens (diameter=14.0mm) for 15 minutes
Lens 2Device
Daily disposable silicone hydrogel contact lens (diameter=14.1mm) for 15 minutes

Study groups in NCT06251154
Study group	Role	What they receive
Lens 1	Experimental	All participants wore Lens 1 for 15 minutes (Period 1) Receives: Device: Lens 1
Lens 2	Experimental	All participants wore Lens 2 for 15 minutes (Period 2) Receives: Device: Lens 2

What is being measured

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

Subjective Overall Score
Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, unmanageable, cannot use lenses and 100=Excellent, highly impressed with these lenses overall
Measured: 15 minutes

Secondary outcomes (2)

Subjective Comfort
Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt
Measured: 15 minutes
Subjective Vision
Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Extremely poor, intolerable, lens cannot be worn and 100=Excellent, unaware of any visual loss
Measured: 15 minutes

Timeline

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

11 Dec 20238 Jan 2024

First posted9 Feb 2024
Study start11 Dec 2023
Primary completion8 Jan 2024
Study completion8 Jan 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: Non-randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06251154
Sponsor's protocol ID: EX-MKTG-154
Status last verified: Jan 2024
First submitted: 30 Jan 2024
Last updated: 22 Aug 2024
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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)
ClinicalTrials.gov ID: NCT06251154
Acronym / sponsor ID: EX-MKTG-154
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 11 Dec 2023 (actual)
Primary completion: 8 Jan 2024 (actual)
Study completion: 8 Jan 2024 (actual)
First posted: 9 Feb 2024 (actual)
Results: Posted 16 Apr 2024

Clinical summary

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

This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Lens 1	Experimental	Device: Lens 1All participants wore Lens 1 for 15 minutes (Period 1)
Lens 2	Experimental	Device: Lens 2All participants wore Lens 2 for 15 minutes (Period 2)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects will only be eligible for the study if:

Key exclusion criteria (10 listed)

Subjects will not be eligible if:

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 1Daily disposable silicone hydrogel contact lens (diameter=14.0mm) for 15 minutes	Device	Lens 1
Lens 2Daily disposable silicone hydrogel contact lens (diameter=14.1mm) for 15 minutes	Device	Lens 2

Primary outcome

Subjective Overall Score
Time frame: 15 minutes
Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, unmanageable, cannot use lenses and 100=Excellent, highly impressed with these lenses overall

2 secondary outcomes

Subjective Comfort
Time frame: 15 minutes
Subjective Vision
Time frame: 15 minutes

Results and safety

Results posted to the registry on 16 Apr 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 1	50	50
Lens 2	0	0

Primary outcome: Subjective Overall Score

Time frame: 15 minutes. Mean (Standard Deviation). Unit: score on a scale

Measure	Lens 1 n = 50	Lens 2 n = 50
Value	80.2 (16.7)	88.2 (11.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of the study, approximately 2 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lens 1	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Lens 2	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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
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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.

Carole Maldonado-Codina, 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 1 and Lens 2 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 6 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 22 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 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 16 Apr 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?

Subjective Overall Score (time frame: 15 minutes). 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 NCT06251154.

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 Aug 2024.