Investigation of Wearing Compliance of Spectacles for Myopia Control

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Myopia control spectacles

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.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. They are amblyopic.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Myopia control spectacle wearers; Established (use of ≥3 months) juvenile myopia control spectacle wearers	Device: Myopia control spectacles; Myopia control spectacles fitted with temperature sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Philip Morgan, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Actual): January 18, 2025
• Study Completion (Actual): January 18, 2025

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes