This trial is active, not recruiting.

Condition myopia
Treatments dual focus soft contact lens, single vision soft contact lens
Phase phase 2
Sponsor Coopervision, Inc.
Collaborator Visioncare Research Ltd.
Start date November 2012
End date May 2017
Trial size 300 participants
Trial identifier NCT01729208, CVI08008


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Dual Focus Soft Contact Lens
dual focus soft contact lens
(Placebo Comparator)
Single Vision Soft Contact Lens
single vision soft contact lens

Primary Outcomes

Change in refractive error relative to baseline
time frame: yearly for 3 years
Change in axial length relative to baseline
time frame: yearly for 3 years

Secondary Outcomes

Incidence of adverse events
time frame: 3 years

Eligibility Criteria

Male or female participants from 8 years up to 12 years old.

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 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.

Additional Information

Official title A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Coopervision, Inc..