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

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Single Vision Soft Contact Lens; Device: Dual Focus Soft Contact Lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01729208

CVI08008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups, including a placebo group

Dual Focus Soft Contact Lens

Experimental group

Description:

Dual Focus Soft Contact Lens

Treatment:

Device: Dual Focus Soft Contact Lens

Single Vision Soft Contact Lens

Placebo Comparator group

Description:

Single Vision Soft Contact Lens

Treatment:

Device: Single Vision Soft Contact Lens