Evaluation of Short Term Use of Experimental Eye Drops BHVI2, 0.02% Atropine and BHVI2 Plus 0.02% Atropine Eye Drops
- Conditions
- Myopia
- Interventions
- Drug: Experimental BHVI2Combination Product: Combination eye drops
- Registration Number
- NCT03690414
- Lead Sponsor
- Hai Yen Eye Care
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental BHVI2 eye drops Experimental BHVI2 20 participants will receive one drop per eye every night for four weeks. 0.02% Atropine eye drops Atropine sulfate 0.02% eye drops 20 participants will receive one drop per eye every night for four weeks. Experimental BHVI2 plus 0.02% atropine Combination eye drops 20 participants will receive one drop per eye every night for four weeks.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Ophthalmology - An Sinh Hospital
🇻🇳Ho Chi Minh City, Vietnam