A Two-year, Randomized, Single-centre, Double-masked, Comparative Study to Evaluate the Annual Rate of Myopia Progression of Children With Myopia Receiving Daily BHVI1, BHVI2 Eye Drops Either Alone or in Combination

Who is this study for? Children with myopia
Status: Active, not recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 13
Healthy Volunteers: Accepts Healthy Volunteers
View:

• be accompanied by a parent or guardian who is able to read and comprehend Vietnamese/English and give informed consent as demonstrated by signing a record of informed consent;

• at baseline, be within the age range of 6 to 13 years old inclusive;

• be diagnosed as myopic having spherical equivalent between -0.50 diopter and-6.00 diopter.

• willing to comply with the applying eye drops once nightly at bedtime and follow the clinical trial visit schedule as directed by the Investigator.

• be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;

• have ocular findings deemed to be normal

• vision correctable to at least 20/25 or better in each eye with spectacles.

Locations
Other Locations
Viet Nam
Department of Ophthalmology - An Sinh Hospital
Ho Chi Minh City
Time Frame
Start Date: October 26, 2019
Estimated Completion Date: October 30, 2022
Participants
Target number of participants: 112
Treatments
Experimental: BHVI1
BHVI1 eye drops
Experimental: BHVI2
BHVI2 eye drops
Experimental: BHVI3
Combination of BHVI1 and BHVI2 eye drops
No Intervention: Non-randomized control group
a separate control group including 105 children enrolled and followed with only single-vision spectacles.
Authors
Thanh N.D. Pham, Huy D.M. Tran, Yen H. Tran
Related Therapeutic Areas
Sponsors
Collaborators: Brien Holden Vision Institute
Leads: Hai Yen Eye Care

This content was sourced from clinicaltrials.gov

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