Myopia
Conditions
Keywords
Myopia control, Atropine eye drops, Caffeine eye drops, Pupillary diameter, Accommodative responses
Brief 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.
Detailed description
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.
Interventions
DRUGExperimental BHVI2
Experimental BHVI2 eye drops
Atropine eye drops
COMBINATION_PRODUCTCombination eye drops
Combination eye drops with experimental BHVI2 plus 0.02% atropine
Sponsors
Brien Holden Vision
Hai Yen Eye Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study treatments will be labelled as A, B and C at the Pharmacy. The masked study products will then be sent to the study coordinator to dispense
Intervention model description
Children aged between 6 to 13 years old. Myopia with spherical equivalent of -0.50D or worse with cylinder of -2.00D or less
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pupillary diameter | At baseline, at two-week and one-month visits | Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops |
| Change in accommodative amplitude | At baseline, at two-week and one-month visits | Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops |
Countries
Vietnam
Outcome results
None listed