An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression

Not Applicable

Completed

Interventions: Device: Dual Focus Soft Contact Lens
Device: Single Vision Soft Contact Lens

Brief Summary: The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Detailed Description: Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Recruitment & Eligibility

Inclusion Criteria

Be between 8 and 12 years of age inclusive.
Best-corrected visual acuity by manifest refraction of +0.10 logMAR.
Spherical Equivalent Refractive Error between -0.75 and -4.00 D
inclusive astigmatism: < -0.75 D and anisometropia: < 1.00 D
Possess wearable and visually functional eyeglasses.
Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study.

Exclusion Criteria

Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.
Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
Any ocular, systemic or neuro-developmental conditions that could influence refractive development.

Arm && Interventions

Group	Intervention	Description
Dual Focus Soft Contact Lens	Dual Focus Soft Contact Lens	Dual Focus Soft Contact Lens
Single Vision Soft Contact Lens	Single Vision Soft Contact Lens	Single Vision Soft Contact Lens

Primary Outcome Measures

Name	Time	Method
Change in Refractive Error Relative to Baseline	36 months	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Change in Axial Length Relative to Baseline	36 months	Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Biomicroscopic Findings Greater Than Grade 2	12 months	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Number of Participants With Biomicroscopic Findings	24 months	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.	36 months	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Incidence of Adverse Events	36 months	Cumulative incidence of adverse events.

Locations (4): University of Minho Clinical & Experiment Optometry Research Lab
🇵🇹
Braga, Portugal
National University of Singapore Faculty of Medicine
🇸🇬
Singapore, Singapore
University of Waterloo School of Optometry
🇨🇦
Waterloo, Ontario, Canada
Aston University Ophthalmic Research Group
🇬🇧
Birmingham, United Kingdom