Evaluation of Short Term Use of Experimental Eye Drops BHVI2, 0.02% Atropine and BHVI2 Plus 0.02% Atropine Eye Drops

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Myopia

Intervention / Treatment
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* Drug: Experimental BHVI2
* Drug: Atropine sulfate 0.02% eye drops
* Combination Product: Combination eye drops


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental BHVI2 eye drops<br>20 participants will receive one drop per eye every night for four weeks. | Drug: Experimental BHVI2<br>* Experimental BHVI2 eye drops<br>|
| Active Comparator: 0.02% Atropine eye drops<br>20 participants will receive one drop per eye every night for four weeks. | Drug: Atropine sulfate 0.02% eye drops<br>* Atropine eye drops<br>|
| Active Comparator: Experimental BHVI2 plus 0.02% atropine<br>20 participants will receive one drop per eye every night for four weeks. | Combination Product: Combination eye drops<br>* Combination eye drops with experimental BHVI2 plus 0.02% atropine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pupillary diameter | Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops | At baseline, at two-week and one-month visits | 
| Change in accommodative amplitude | Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops | At baseline, at two-week and one-month visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia control, Atropine eye drops, Caffeine eye drops, Pupillary diameter, Accommodative responses