Using Contact Lenses and Spectacle Lenses as Myopia Interventions.

ConditionMyopia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age11-17

SponsorCooperVision International Limited (CVIL)

About this trial

Effect of alternating contact lenses and spectacles for myopia control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are aged 11 to 17 years (inclusive);

Have successfully completed the 4-year MiSight® Analysis of Progression (MAP) Study;

Are established soft contact lens wearers (including myopia control contact lens designs);

Have read and signed the study consent or assent form, as appropriate for their age;

Disqualifiers

Are participating in any concurrent clinical or interventional study;

Have worn rigid gas-permeable (including orthokeratology) contact lenses within the previous 30 days;

Have used atropine concentrations above 0.01% for myopia control in the previous 30 days;

Are extended-wear contact lens users (i.e., sleep in their lenses);

Trial design

Design model

Parallel

Treatments tested in this trial

Test Spectacle Lens & Contact Lens
Device
Participants will wear contact lenses for a target of 10 hours a day, 5 days per week and test spectacle lenses for remaining waking hours.
Control Spectacle Lens & Contact Lens
Device
Participants will wear contact lenses for a target of 10 hours a day, 5 days per week and control spectacle lenses for remaining waking hours.

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: Test GroupExperimental treatment 1 intervention

Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in axial length (AXL, mm) over 12 months

Time frame

Over 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CooperVision International Limited (CVIL)

Lead sponsor

SightGlass Vision, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: