Investigation of Wearing Compliance of Spectacles for Myopia Control

NCT ID: NCT06590441

Last Updated: 2025-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-01-18

Brief Summary

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

Detailed Description

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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

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Myopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Myopia control spectacle wearers

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

Myopia control spectacles

Intervention Type DEVICE

Myopia control spectacles fitted with temperature sensors

Interventions

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Myopia control spectacles

Myopia control spectacles fitted with temperature sensors

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CooperVision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Morgan

Role: PRINCIPAL_INVESTIGATOR

Eurolens Research

Locations

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Eye2C Ltd

Sale, Cheshire, United Kingdom

Site Status

Susan Hilton Ltd

Darwen, England, United Kingdom

Site Status

Columbo Ltd

Oakwood, Leeds, United Kingdom

Site Status

David Gould Opticians Limited

Haslingden, Rossendale, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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EX-MKTG-160

Identifier Type: -

Identifier Source: org_study_id

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