Evaluation of Contact Lenses and Myopia.
ConditionPre-myopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-10
SponsorCooperVision International Limited (CVIL)
About this trial
This study will evaluate the effect of dual focus contact lenses on Myopia prevention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female children aged between 8-10 years inclusive.
Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.
Astigmatism ≤ -1.00D in both eyes.
Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.
Disqualifiers
History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month)
Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
Ocular or systemic disease that contraindicates contact lens wear.
Trial design
Design model
Single group
Treatments tested in this trial
Test Lens - Dual Focus
DeviceDual-Focus Contact Lens
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: Test LensExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Myopia onset (cycloplegic SER ≤ -0.50D) in either or both eyes at 2 years.
Time frame
Through study completion, 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
CooperVision International Limited (CVIL)
Lead sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborator
Source ClinicalTrials.gov