A One-month, Randomized, Single Centre, Double-masked, Comparative Study to Evaluate the Short-term Ocular Effects of Experimental BHVI2 and 0.02% Atropine Eye Drops Either Alone or in Combination

Date de début de l'étude : 1 octobre 2018

Inclusion Criteria: * 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 atropine and caffeine such as pulmonary disease, heart conditions and ADHD * Known allergy or intolerance to ingredients to atropine eye-drops, xanthines and other derivatives of anti-muscarinic receptor agents. * Currently enrolled in another clinical trial.