A Two-year, Randomized, Single-centre, Double-masked, Comparative Study to Evaluate the Annual Rate of Myopia Progression of Children With Myopia Receiving Daily BHVI1, BHVI2 Eye Drops Either Alone or in Combination
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Spherical equivalent
研究概览
简要总结
Myopia currently affects 30% of the world and by 2050, almost 50% of the world will be myopic based on conservative estimates.1 In 2050, this will equate to almost 5 billion people with myopia, and those with high myopia will total almost 1 billion.1 Due to the growing public health concerns surrounding myopia, including treatments for visual complications associated with high myopia, the resultant lost productivity and increased cost to society, a solution to ameliorate this issue is imperative.
Current treatment strategies cannot prevent myopia, and their ability to slow myopia progression is variable, ranging from 10% to 59%.2 Based on the meta-analysis between the different interventions for myopia control, atropine eye-drops were proved the most effective strategy.3 Atropine has been used in myopia control treatment over the last 30 years in many countries with no serious adverse events reported.4-6 Moreover, atropine, a non-selective antimuscarinic agent, has been regularly applied in multiple other ocular conditions with respect to the official FDA approvals.7 8 Regarding the myopia management, recent studies show the significant effect of low dose atropine in controlling the progression of spherical equivalent with the least side-effects such as photophobia and blurry near vision.9 However, the lack of substantial data in reducing the axial growth rate of low dose atropine proposes a need of either using higher dose of atropine or in combination with other pharmaceutical agent having such the effect.
We therefore aim to determine in a two-year clinical trial, the efficacy of the eye drops used in our clinical trial for its role in slowing progression of myopia.
详细描述
6.1. NULL HYPOTHESES
There is no difference in the rate of progression of myopia as determined by change in spherical equivalent refractive error over time between PX using test eye drops compared to PX in the control arm.
There is no difference in the rate of progression of myopia as determined by change in axial length over time between PX using test eye drops compared to PX in the control arm.
6.2. DESCRIPTION Statistical analysis is planned to commence on completion of trial monitoring and the submission of the data analysis request form. Any interim analysis will be conducted as described in this section unless a documented request is received from the Sponsor and approved by the trial PI.
Data stored in relational databases will be imported into SPSS / STATA software for statistical purposes. Data will be investigated for quality using range checks and frequency distribution. Underlying distributions of variables will be tested. In general, variables measured on an interval scale with a sufficiently large sample size will be considered to follow a normal distribution. Outputs from the statistical analysis such as statistical tables will be copied over to Excel. All statistical results will be reported in Excel format.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In the interventions group, the participants and the investigators will be masked to the nature of the drop dispensed. Upon receiving the product, the product will be coded and masked by a person other than the clinicians involved in the study. Only coded and masked product will be dispensed to the participant.
Unmasking should only occur in the case of an adverse event if knowledge of the trial treatment would alter the plan of care for the participant. If at all possible (if time permits) the Sponsor / The Independent Pharmacist should be consulted prior to unmasking. Thorough documentation must occur, and exposure to treatment knowledge should be limited only to those who must know.
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
- •Subjects enrolled in the trial must:
- •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 the products used in the trial such as pulmonary disease, heart conditions and ADHD
- •Known allergy or intolerance to ingredients to eye-drops used in the trial and other related derivatives.
- •Currently enrolled in another clinical trial.
研究组 & 干预措施
BHVI1
BHVI1 eye drops
干预措施: BHVI1 eye drops (Drug)
BHVI2
BHVI2 eye drops
干预措施: BHVI2 eye drops (Drug)
BHVI3
Combination of BHVI1 and BHVI2 eye drops
干预措施: BHVI3 eye drops (Drug)
结局指标
主要结局
Spherical equivalent
时间窗: at baseline visit, at one-year and two-year visits
Annual change in spherical equivalent from baseline
次要结局
- Axial length(at baseline visit, at one-year and two-year visits)