MyopiaNCT06590441

Investigation of Wearing Compliance of Spectacles for Myopia Control

An observational study of Myopia, run by CooperVision, Inc. at 4 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this observational study was to compare the wearing patterns of spectacles prescribed for myopia control in juvenile wearers. Read more about this study

Who is it for?: Ages 6 to 15 years
Conditions the study is for: Myopia
Type of treatment: Medical device
How many people: 53 participants
Where: 4 sitesUnited Kingdom
Study dates: 30 Sep 2024to 18 Jan 2025
Phase: Observational
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 6 to 15 years
All sexes
No healthy volunteers
Child

Study population: Juvenile participants recruited directly from the patient bases of several UK optometry practices who currently wear spectacles prescribed for myopia

Who may be able to join

They are aged between six and 15 years old.
Their parent or guardian understands the rights of the subject and are willing to sign a statement of informed consent.
They understand the study at a level appropriate for their age and are willing to sign a statement of assent.
They and their parents or guardians are willing and able to follow the protocol.
They currently use spectacle lenses for myopia control and have done so for at least three months.
They agree not to participate in other clinical research for the duration of this study.

Who cannot join

They have an unusual ophthalmic history, which in the opinion of the site investigator or Principal Investigator might impact on the successful conduct of the study.
They are amblyopic.

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

Susan Hilton Ltd
Darwen, England, BB3 2AA
David Gould Opticians Limited
Haslingden, Rossendale, BB4 5QN
Columbo Ltd
Oakwood, Leeds, LS8 2HU
Eye2C Ltd
Sale, Cheshire, M33 7XF

Other trials in United Kingdom

About this study

Official title: A Multisite Investigation of the Wearing Compliance of Spectacles for Myopia Control

The goal of this observational study was to compare the wearing patterns of spectacles prescribed for myopia control in juvenile wearers.

Read the detailed description

This unmasked, multi-center, observational study evaluated the wearing patterns of established (use of ≥3 months) juvenile spectacles wearers. It aimed to compare the wearing patterns of spectacles for myopia control between males and females. Wearing pattern were measured via the use of temperature sensors fitted to the sides of the participant's spectacles. Data from the final week of the 1-month study was used for analysis to minimize 'unusual' wear patterns which may have occurred early in the study.

Conditions: Myopia
Being tested: Myopia control spectacles
Medical subject headings: Myopia

What participants receive

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

Myopia control spectaclesDevice
Myopia control spectacles fitted with temperature sensors

Study groups in NCT06590441
Study group	Role	What they receive
Myopia control spectacle wearers		Established (use of ≥3 months) juvenile myopia control spectacle wearers Receives: Device: Myopia control spectacles

What is being measured

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

Overall Wearing Pattern of Myopia Control Spectacles
Overall wearing patterns were evaluated via the use of temperature sensors fitted to the frame of the spectacles. The temperature readings from the final week of the one month study were used to determine when spectacles were worn or removed. Scores were calculated as the average times over a 24 hour period (W24) where a higher score indicated that the spectacles were worn for a longer period of time per day.
Measured: Measured continuously over 1 week of wear
Effect of Sex on Overall Wearing Pattern
The effect of sex on the overall wearing pattern was evaluated via the use of temperature sensors fitted to the frame of the spectacles. The temperature readings from the final week of the one month study were used to determine when spectacles were worn or removed. Scores were calculated as the average times over a 24 hour period (W24) and a 'waking day' period of 07:00 to 21:00 (W14), where a higher score indicated that the spectacles were worn for a longer period of time per day.
Measured: Measured continuously over 1 week of wear

Timeline

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

30 Sep 202418 Jan 2025

First posted19 Sep 2024
Study start30 Sep 2024
Primary completion18 Jan 2025
Study completion18 Jan 2025

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06590441
Sponsor's protocol ID: EX-MKTG-160
Status last verified: Oct 2025
First submitted: 30 Aug 2024
Last updated: 25 Nov 2025
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

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

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multisite Investigation of the Wearing Compliance of Spectacles for Myopia Control
ClinicalTrials.gov ID: NCT06590441
Acronym / sponsor ID: EX-MKTG-160
Conditions: Myopia
Study type: Observational
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 30 Sep 2024 (actual)
Primary completion: 18 Jan 2025 (actual)
Study completion: 18 Jan 2025 (actual)
First posted: 19 Sep 2024 (actual)
Results: Posted 25 Nov 2025

Clinical summary

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

The goal of this observational study was to compare the wearing patterns of spectacles prescribed for myopia control in juvenile wearers.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Myopia control spectacle wearers	–	Device: Myopia control spectaclesEstablished (use of ≥3 months) juvenile myopia control spectacle wearers

Who may qualify

Ages: 6 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Juvenile participants recruited directly from the patient bases of several UK optometry practices who currently wear spectacles prescribed for myopia

Key inclusion criteria (6 listed)

They are aged between six and 15 years old.
Their parent or guardian understands the rights of the subject and are willing to sign a statement of informed consent.
They understand the study at a level appropriate for their age and are willing to sign a statement of assent.
They and their parents or guardians are willing and able to follow the protocol.
They currently use spectacle lenses for myopia control and have done so for at least three months.

Key exclusion criteria (2 listed)

They have an unusual ophthalmic history, which in the opinion of the site investigator or Principal Investigator might impact on the successful conduct of the study.
They are amblyopic.

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
Myopia control spectaclesMyopia control spectacles fitted with temperature sensors	Device	Myopia control spectacle wearers

Primary outcome

Overall Wearing Pattern of Myopia Control Spectacles
Time frame: Measured continuously over 1 week of wear
Overall wearing patterns were evaluated via the use of temperature sensors fitted to the frame of the spectacles. The temperature readings from the final week of the one month study were used to determine when spectacles were worn or removed. Scores were calculated as the average times over a 24 hour period (W24) where a higher score indicated that the spectacles were worn for a longer period of time per day.
Effect of Sex on Overall Wearing Pattern
Time frame: Measured continuously over 1 week of wear
The effect of sex on the overall wearing pattern was evaluated via the use of temperature sensors fitted to the frame of the spectacles. The temperature readings from the final week of the one month study were used to determine when spectacles were worn or removed. Scores were calculated as the average times over a 24 hour period (W24) and a 'waking day' period of 07:00 to 21:00 (W14), where a higher score indicated that the spectacles were worn for a longer period of time per day.

Results and safety

Results posted to the registry on 25 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Myopia Control Spectacles	53	53

Primary outcome: Overall Wearing Pattern of Myopia Control Spectacles

Time frame: Measured continuously over 1 week of wear. Mean (Standard Deviation). Unit: Hours in a day

Measure	Myopia Control Spectacles n = 52
Value	12.8 (4.1)

Population analysed: Data for one participant was not available due to a failure of the sensors

Primary outcome: Effect of Sex on Overall Wearing Pattern

Time frame: Measured continuously over 1 week of wear. Least squares mean (95% Confidence Interval). Unit: Hours in a day

Measure	Female Participants n = 29	Male Participants n = 23
W14	12 (11.0 to 13.0)	10.4 (9.2 to 11.5)
W24	13.9 (12.6 to 15.1)	11.5 (10.1 to 12.9)

Adverse events

Time frame: Duration of the study, approximately one month.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Myopia Control Spectacles	0 of 53 (0%)	0 of 53 (0%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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 principal investigator

Eurolens Research

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

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia, run by CooperVision, Inc. at 4 sites 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 2 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 25 Nov 2025. 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 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 25 Nov 2025). 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 Wearing Pattern of Myopia Control Spectacles (time frame: Measured continuously over 1 week of wear). The study lists 2 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 NCT06590441.

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 25 Nov 2025.