Status:
COMPLETED
Myopia Control With Novel Eye Drops
Lead Sponsor:
Hai Yen Eye Care
Collaborating Sponsors:
Brien Holden Vision Institute
Conditions:
Myopia
Eligibility:
All Genders
6-13 years
Phase:
PHASE1
PHASE2
Brief 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 th...
Detailed Description
6.1. NULL HYPOTHESES There is no difference in the rate of progression of myopia as determined by change in spherical equivalent refractive error over time between PX using test eye drops compared to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04301323
Start Date
October 26 2019
End Date
October 30 2022
Last Update
September 22 2023
Active Locations (1)
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1
Department of Ophthalmology - An Sinh Hospital
Ho Chi Minh City, Vietnam, 700000