MyopiaNCT05741450

A Clinical Comparison of Two Soft Contact Lenses

A study testing Lens 1 (monthly replacement) and Lens 2 (daily disposable) in people with Myopia and Hyperopia, 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 study objective was to gather short-term clinical performance data for two soft contact lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Hyperopia
What is being tested?: Lens 1 (monthly replacement) and Lens 2 (daily disposable)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited Kingdom
Study dates: 24 Nov 2022to 5 Dec 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

They are of legal age (18) and 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 currently wear soft contact lenses, or have done so within the past two years.
They are expected to be able to be fitted with the study lenses within the power range available.

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 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 lactating.
They have an eye or health condition including an immunosuppressive or infectious disease which would, 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 have 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

Other trials in United Kingdom

About this study

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

The study objective was to gather short-term clinical performance data for two soft contact lenses.

Read the detailed description

The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.

Conditions: Myopia, Hyperopia
Being tested: Lens 1 (monthly replacement), Lens 2 (daily disposable)
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 1 (monthly replacement)Device
Monthly replacement spherical silicone hydrogel contact lens for 15 minutes
Lens 2 (daily disposable)Device
Daily disposable spherical silicone hydrogel contact lens for 15 minutes

Study groups in NCT05741450
Study group	Role	What they receive
Lens 1	Experimental	All participants wore Lens 1 for 15 minutes (Period 1) Receives: Device: Lens 1 (monthly replacement)
Lens 2	Experimental	All participants wore Lens 2 for 15 minutes (Period 2) Receives: Device: Lens 2 (daily disposable)

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, 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=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=Unacceptable, 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.

24 Nov 20225 Dec 2022

First posted23 Feb 2023
Study start24 Nov 2022
Primary completion5 Dec 2022
Study completion5 Dec 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: Non-randomised
Intervention model: Crossover
Model description: All participants received Lens 1 and then Lens 2 in fixed-sequence order.
Masking: Single blind
Who is masked: Participant
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05741450
Sponsor's protocol ID: C22-724 (EX-MKTG-138)
Status last verified: Feb 2023
First submitted: 14 Feb 2023
Last updated: 10 Jan 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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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 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: NCT05741450
Acronym / sponsor ID: C22-724 (EX-MKTG-138)
Conditions: Myopia, Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 24 Nov 2022 (actual)
Primary completion: 5 Dec 2022 (actual)
Study completion: 5 Dec 2022 (actual)
First posted: 23 Feb 2023 (actual)
Results: Posted 10 Jan 2024

Clinical summary

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

The study objective was to gather short-term clinical performance data for two soft contact lenses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: All participants received Lens 1 and then Lens 2 in fixed-sequence order.

Arm	Type	Receives
Lens 1	Experimental	Device: Lens 1 (monthly replacement)All participants wore Lens 1 for 15 minutes (Period 1)
Lens 2	Experimental	Device: Lens 2 (daily disposable)All 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 (5 listed)

They are of legal age (18) and 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 currently wear soft contact lenses, or have done so within the past two years.
They are expected to be able to be fitted with the study lenses within the power range available.

Key exclusion criteria (9 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 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 1 (monthly replacement)Monthly replacement spherical silicone hydrogel contact lens for 15 minutes	Device	Lens 1
Lens 2 (daily disposable)Daily disposable spherical silicone hydrogel contact lens 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, 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 10 Jan 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 (Monthly Replacement)	45	45
Lens 2 (Daily Disposable)	0	0

Primary outcome: Subjective Overall Score

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

Measure	Lens 1 n = 44	Lens 2 n = 44
Value	84.7 (15.5)	82.5 (14.6)

Population analysed: One participant was excluded from data analysis due to issues during lens application

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The duration of the clinical trial, approximately 1.5 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lens 1	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Lens 2	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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
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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.

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 1 (monthly replacement) and Lens 2 (daily disposable) in people with Myopia and Hyperopia, 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 5 inclusion and 9 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 10 Jan 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 10 Jan 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 NCT05741450.

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 10 Jan 2024.