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
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.
• 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.