Myopia Control With Novel Eye Drops

• Status: Active, not recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hai Yen Eye Care
• Collaborator: Brien Holden Vision Institute
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria: Subjects enrolled in the trial must:

• 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.

Exclusion Criteria: Subjects enrolled in the trial must NOT have:

• Any pre-existing ocular irritation, allergic conjunctivitis, injury or condition, including infection or disease.

• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.

• Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.

• Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.

• NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.

• History of eye trauma

• History of use of myopia control interventions such as Orthokeratology or eye surgery.

• Contraindications to the products used in the trial such as pulmonary disease, heart conditions and ADHD

• Known allergy or intolerance to ingredients to eye-drops used in the trial and other related derivatives.

• Currently enrolled in another clinical trial.