Clinical trial NCT01729208: An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression
Official title: A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia progression
myopia control
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2012-11-20
Enrollment: 144
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Refractive Error Relative to Baseline
timeFrame: 12 months
measure: Change in Refractive Error Relative to Baseline
timeFrame: 24 months
measure: Change in Refractive Error Relative to Baseline
timeFrame: 36 months
measure: Change in Axial Length Relative to Baseline
timeFrame: 12 months
measure: Change in Axial Length Relative to Baseline
timeFrame: 24 months
measure: Change in Axial Length Relative to Baseline
timeFrame: 36 months
Secondary outcomes:
measure: Number of Participants With Biomicroscopic Findings Greater Than Grade 2
timeFrame: Baseline
measure: Number of Participants With Biomicroscopic Findings Greater Than Grade 2
timeFrame: 12 months
measure: Number of Participants With Biomicroscopic Findings
timeFrame: 24 months
measure: Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
timeFrame: 36 months
measure: Incidence of Adverse Events
timeFrame: 12 months
measure: Incidence of Adverse Events
timeFrame: 24 months
measure: Incidence of Adverse Events
timeFrame: 36 months
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo School of Optometry
state: Ontario
city: Braga
country: Portugal
facility: University of Minho Clinical & Experiment Optometry Research Lab
city: Singapore
country: Singapore
facility: National University of Singapore Faculty of Medicine
city: Birmingham
country: United Kingdom
facility: Aston University Ophthalmic Research Group
Study officials:
affiliation: University of Minho
name: José Manuel González-Méijome
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chamberlain P, Bradley A, Arumugam B, Hammond D, McNally J, Logan NS, Jones D, Ngo C, Peixoto-de-Matos SC, Hunt C, Young G. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. doi: 10.1097/OPX.0000000000001873.
citation: Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019 Aug;96(8):556-567. doi: 10.1097/OPX.0000000000001410.