Trial Outcomes & Findings for Investigation of Wearing Compliance of Spectacles for Myopia Control (NCT NCT06590441)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

53 participants

Primary outcome timeframe

Measured continuously over 1 week of wear

Results posted on

2025-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Myopia Control Spectacles All participants wore their habitual myopia control spectacles
Overall Study STARTED	53
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Myopia Control Spectacles n=53 Participants All participants of the clinical study
Age, Continuous	11.2 years STANDARD_DEVIATION 2.0 • n=53 Participants
Sex: Female, Male Female	29 Participants n=53 Participants
Sex: Female, Male Male	24 Participants n=53 Participants

PRIMARY outcome

Timeframe: Measured continuously over 1 week of wear

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

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.

Outcome measures

Outcome measures
Measure	Myopia Control Spectacles n=52 Participants Participants that wore habitual myopia control spectacles with fully working sensors	Male Participants Male participants that wore habitual myopia control spectacles with fully working sensors
Overall Wearing Pattern of Myopia Control Spectacles	12.8 Hours in a day Standard Deviation 4.1	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Myopia Control Spectacles n=29 Participants Participants that wore habitual myopia control spectacles with fully working sensors	Male Participants n=23 Participants Male participants that wore habitual myopia control spectacles with fully working sensors
Effect of Sex on Overall Wearing Pattern W14	12 Hours in a day Interval 11.0 to 13.0	10.4 Hours in a day Interval 9.2 to 11.5
Effect of Sex on Overall Wearing Pattern W24	13.9 Hours in a day Interval 12.6 to 15.1	11.5 Hours in a day Interval 10.1 to 12.9

Adverse Events

Myopia Control Spectacles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

José A. Vega

CooperVision Inc.

Phone: +1 (925) 621-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place