Investigation of Wearing Compliance of… | Clinical Trial

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye2C Ltd, Sale, Cheshire, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Myopia control spectacles

Device

Myopia control spectacles fitted with temperature sensors

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

A Multisite Investigation of the Wearing Compliance of Spectacles for Myopia Control

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 19, 2024
Registry last updated: Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed