Investigation of Wearing Compliance of Spectacles for Myopia Control

NCT06590441 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-160
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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 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 continuously over 1 week of wear

Study Arms (1)

Myopia control spectacle wearers

Established (use of ≥3 months) juvenile myopia control spectacle wearers

Device: Myopia control spectacles

Interventions

Myopia control spectacles DEVICE

Myopia control spectacles fitted with temperature sensors

Myopia control spectacle wearers

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

Eye2C Ltd

Sale, Cheshire, M33 7XF, United Kingdom

Location

Susan Hilton Ltd

Darwen, England, BB3 2AA, United Kingdom

Location

Columbo Ltd

Oakwood, Leeds, LS8 2HU, United Kingdom

Location

David Gould Opticians Limited

Haslingden, Rossendale, BB4 5QN, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega
• Organization: CooperVision Inc.

JVega2@coopervision.com

+1 (925) 621-3761

Study Officials

• Philip Morgan

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion: January 18, 2025
• Study Completion: January 18, 2025
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-10

Locations

GB (4)