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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dual Focus Soft Contact Lens Wear Cessation Study

NCT05779072

Myopia

COMPLETED NA

Management of Myopia in University Students Using Dual Focus Soft Contact Lenses

NCT05955638

Myopia, Progressive

ENROLLING_BY_INVITATION NA

Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

NCT01829191

Myopia

COMPLETED NA

Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults

NCT06528860

Myopia

NOT_YET_RECRUITING NA

Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses

NCT06221592

Myopia, Progressive

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dual Focus Soft Contact Lens

Group Type EXPERIMENTAL

Dual Focus Soft Contact Lens

Intervention Type DEVICE

Single Vision Soft Contact Lens

Group Type PLACEBO_COMPARATOR

Single Vision Soft Contact Lens

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dual Focus Soft Contact Lens

Intervention Type DEVICE

Single Vision Soft Contact Lens

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No