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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in pupillary diameter
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Experimental BHVI2 eye drops
20 participants will receive one drop per eye every night for four weeks.
干预措施: Experimental BHVI2 (Drug)
0.02% Atropine eye drops
20 participants will receive one drop per eye every night for four weeks.
干预措施: Atropine sulfate 0.02% eye drops (Drug)
Experimental BHVI2 plus 0.02% atropine
20 participants will receive one drop per eye every night for four weeks.
干预措施: Combination eye drops (Combination Product)
结局指标
主要结局
Change in pupillary diameter
时间窗: 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
时间窗: At baseline, at two-week and one-month visits
Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops
次要结局
未报告次要终点