Myopia Control With Novel Eye Drops

Summary

Myopia currently affects 30% of the world and by 2050, almost 50% of the world will be myopic based on conservative estimates.1 In 2050, this will equate to almost 5 billion people with myopia, and those with high myopia will total almost 1 billion.1 Due to the growing public health concerns surrounding myopia, including treatments for visual complications associated with high myopia, the resultant lost productivity and increased cost to society, a solution to ameliorate this issue is imperative.

Current treatment strategies cannot prevent myopia, and their ability to slow myopia progression is variable, ranging from 10% to 59%.2 Based on the meta-analysis between the different interventions for myopia control, atropine eye-drops were proved the most effective strategy.3 Atropine has been used in myopia control treatment over the last 30 years in many countries with no serious adverse events reported.4-6 Moreover, atropine, a non-selective antimuscarinic agent, has been regularly applied in multiple other ocular conditions with respect to the official FDA approvals.7 8 Regarding the myopia management, recent studies show the significant effect of low dose atropine in controlling the progression of spherical equivalent with the least side-effects such as photophobia and blurry near vision.9 However, the lack of substantial data in reducing the axial growth rate of low dose atropine proposes a need of either using higher dose of atropine or in combination with other pharmaceutical agent having such the effect.

We therefore aim to determine in a two-year clinical trial, the efficacy of the eye drops used in our clinical trial for its role in slowing progression of myopia.

Conditions

• Myopia

Interventions

DRUG

BHVI1 eye drops

Including 35 children enrolled to receive BHVI1 eye-drops once nightly

DRUG

BHVI2 eye drops

Including 35 children enrolled to receive BHVI2 eye-drops once nightly

DRUG

BHVI3 eye drops

Including 35 children enrolled to receive BHVI3, combination of BHVI1 and BHVI2, eye-drops once nightly

Sponsors & Collaborators

• Brien Holden Vision Institute

  collaborator OTHER

• Hai Yen Eye Care

  lead INDUSTRY

Principal Investigators

• Padmaja Sankaridurg, Professor · Brien Holden Vision Institute; School of Optometry and Vision Science - University of New South Wales

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-26

Primary Completion

2022-06-30

Completion

2022-10-30

Countries

• Vietnam

Study Locations