The Effect of Myopia-Control Contact Lenses in New Zealand Chinese Children
ConditionMyopia Progression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age7-11
SponsorAston University
About this trial
The study will employ a randomized, controlled, investigator-masked paired-eye comparison design to evaluate the effects of two myopia-control contact lenses-MiSight 1 Day and Abiliti 1-Day-in New Zealand Chinese children.
The study duration will be 6 months, with assessments conducted at baseline, 2 weeks, 3 months, and 6 months.
The clinical research will be conducted at the Auckland Myopia Clinic (New Zealand) and will follow a standard clinical routine for children with early myopia, the only difference being the randomizing of the MiSight and Abiliti contact lenses between the two eyes of the participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Spherical refractive error between -1.00D and -4.50D
Astigmatism of ≤1.00D
No history of orthokeratology or atropine use
No ocular diseases or surgical history
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
MiSight Contact Lenses (CooperVision)
DeviceMyopia Control Contact Lens
Albiliti 1-Day (Johnson and Johnson, VisionCare)
DeviceMyopia Control Contact Lens
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: MiSight Contact LensActive comparator 1 intervention
Group B: Abiliti 1-DayActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Spherical Equivalent Cycloplegic Refraction
The dioptric refractive error as determined by retinoscopy following cycloplegic refraction
Time frame
Baseline, 2 weeks, 3 months, 6 months2
Axial length
Ocular biometry measured with Myah biometer
Time frame
Baseline, 2 weeks, 3 months, 6 monthsSecondary outcomes
1
Children Dry Eye Questionnaire (CDEQ) response
Total score derived from the Children Dry Eye Questionnaire (CDEQ)
Time frame
Baseline, 2 weeks, 3 months, 6 months2
Non-invasive Tear break-up time
Non-invasive Tear break-up time (NIBUT) using MYAH's objective dry eye function - time after a blink (in seconds) for the first break in the tear film to be detected
Time frame
Baseline, 2 weeks, 3 months, 6 months3
Ocular Protection Index
Non-invasive breakup time secondary outcome measure divided by the average blink interval (number of blinks observed in a 60s period)
Time frame
Baseline, 2 weeks, 3 months, 6 months4
Corneal punctate spots
Number of punctate spots observed on the cornea following instillation of fluorescein and illumination with a blue light source
Time frame
Baseline, 2 weeks, 3 months, 6 monthsSponsors and contacts
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Source ClinicalTrials.gov