evaluation of short term use of experimental eye drops bhvi2, 0.02% atropine and bhvi2 plus 0.02% atropine eye drops

Conditions: Myopia

Summary: to assess the one-month ocular effects of nightly application of experimental bhvi2 and 0.02% atropine eye drops either alone or in combination, in children aged between 6 to 13 years old with myopia and randomized to use of experimental bhvi2 eye drops, 0.02% atropine eye drops, experimental bhvi2 plus 0.02% atropine eye drops.

atropine was proven to be effective in controlling myopia. 7-methylxanthine was considered to play a role in slowing myopia. the experimental bhvi2 eye drops were proven to be safe for in-eye use in the trial that was conducted in sydney, australia. the investigators wish to evaluate the effects of experimental bhvi2 and 0.02% atropine eye drops either alone or in combination mainly on the pupillary and accommodative responses in children aged between 6 to 13 years old over a one-month period.

Eligibility criteria:
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.

Keywords: myopia control atropine eye drops caffeine eye drops pupillary diameter accommodative responses