A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses

Coopervision, Inc.4 sites in 4 countries144 target enrollmentNovember 2012

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Coopervision, Inc.
Enrollment: 144
Locations: 4
Primary Endpoint: Change in Refractive Error Relative to Baseline
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

May 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Change in Refractive Error Relative to Baseline

Time Frame: 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

Time Frame: 36 months

Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.

Secondary Outcomes

Number of Participants With Biomicroscopic Findings Greater Than Grade 2(12 months)
Number of Participants With Biomicroscopic Findings(24 months)
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.(36 months)
Incidence of Adverse Events(36 months)