To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.

Summary

Myopia is a common disorder, affecting approximately one-third of the US population and over 90% of the population in some East Asian countries. High amounts of myopia are associated with an increased risk of sight-threatening problems, such as retinal detachment, choroidal degeneration, cataracts, and glaucoma. Slowing the progression of myopia could potentially benefit millions of children. To date, few strategies used for myopia control have proven to be effective. Currently, there are four categories of myopia control treatments: atropine eye drops, multifocal contact lenses, multifocal eyeglasses, and orthokeratology (ortho-k). None of these modalities are US Food and Drug Administration-approved to slow myopia progression, they have been shown to slow the progression by approximately 50% with few risks. Both orthokeratology and soft bifocal contact lenses have shown to slow myopia progression by slightly less than 50% in most studies.

The Myolens progressive front soft contact lens is designed to slow down myopia progression in children, The Myolens lens is an aspheric design with a spherical back surface that provides clear vision, with a uniform round edge for excellent fit and optimum comfort.

The Myolens-CN is designed with a central for the near optics, while the Myolens-CF with a central for the distance optics, which progressively changes to far area and within a defined optical zone area while considering the movement up-down of the lens on the cornea.

The thought behind the design is that the center of the lens will not provide a full optical correction.

In the suggested study, both Myolens modalities CN and CF will be investigated in compare to the current approved treatment - MiSight.

Conditions

• Myopia

Interventions

DEVICE

Myolens CN (Central-Near) soft contact lens

Personal fitting of the Myolens-CN/CF.

DEVICE

MiSight® soft contact lens

Control arm device, FDA approved (P180035), and CE marked soft lenses for the management of Myopia in children aged 8-12.

Sponsors & Collaborators

• RSNESS

  collaborator UNKNOWN

• Fitlens Ltd.

  lead INDUSTRY

Principal Investigators

• Nitza Cohen, MD · Bnei- Zion MC. Israel

• Oriel Shpirer, MD · Wolfson MC. Israel

• Shiri Shulman, MD · Assuta- Hashalom MC. Israel

• José M González Méijome, MD · University of Minho- Portugal

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-10

Primary Completion

2026-01-31

Completion

2026-01-31

Countries

• Israel

Study Locations