A prospective, randomized, multicentre, open-label study to evaluate the safety and effectiveness of Menicon Bloom Night lenses compared to an available registered brand of orthokeratology lenses, and spectacles for myopia control, and single vision spectacles in Indian children
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary effectiveness endpoints:
研究概览
简要总结
Myopia is one of the most common refractive errors and a major cause of vision impairment worldwide. While Menicon Bloom Night™ lenses have shown effectiveness in controlling myopia progression globally, clinical data in the Indian pediatric population remains limited. Given the rising prevalence of myopia in India, especially among school-going children, evaluating MBN’s safety and efficacy compared to existing myopia control methods (registered Ortho-K lenses, myopia control spectacles, and single vision spectacles) is crucial for evidence-based recommendations.
Therefore, this study is designed to investigate the safety and the effectiveness for myopia correction and myopia control of Menicon Bloom Night lenses compared to an available registered brand of orthokeratology lenses, myopia control spectacles, and single vision spectacles in Indian children for academic and marketing purpose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with myopia and myopic astigmatism.
- •2.Patients aged between above or equal to 6 and under or equal to 15 years old at baseline examination.
- •3.Keratometry: 37 to 52 D (diopter) 4.Fully understand the purpose of the clinical study and agree to sign the informed consent form to participate in clinical study, based on his/her willingness.
- •5.Patients who can visit the institution on scheduled dates 6.Patients who can receive guidance and tests as required by the investigator 7.Patients who fully understand and follow the instructions of the lenses for this clinical study.
排除标准
- •Best corrected vision acuity of more than 0.1 logMAR (less than 6/7.5 Snellen) with spectacles
- •Subjective refraction test shows spherical power greater than -4.00D, less than -0.50D or astigmatism greater than 1.5D or anisometropia greater than 1.5D.
- •Presence of Strabismus at distance or near
- •Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses)
- •The medical history of intraocular surgery that may affect the effect of wearing orthokeratology lenses (those with corneal transplantation, retinal detachment, etc.)
- •The medical history of refractive corneal surgery
- •Having eye allergic diseases that may cause disorders in wearing orthokeratology lenses
- •All corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, low corneal endothelial cell counts
- •Patients who are participating in other clinical studies or have participated in other clinical studies in the past 30 days
- •Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days
- •Prior history of myopia control treatment within 06 months (e.g. atropine, orthokeratology, multifocal soft contact lenses, spectacles designed for myopia control, red light therapy)
- •Deemed inappropriate for participation in this study by an ophthalmologist after detailed eye health check.
结局指标
主要结局
Primary effectiveness endpoints:
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
1. Axial elongation (for Myopia control efficacy): [Timeframe:
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
Screening, month 03, 06 and 12]
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12]
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12]
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12]
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
5. IOP (for Safety): [Timeframe: Screening, month 12]
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
6. Corneal endothelial cell (for Safety): [Timeframe: Screening,month 12]
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12]
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
时间窗: Primary effectiveness endpoints: | 1. Axial elongation (for Myopia control efficacy): [Timeframe: | Screening, month 03, 06 and 12] | 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] | 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] | 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] | 5. IOP (for Safety): [Timeframe: Screening, month 12] | 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] | 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] | 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12
次要结局
- 1. Corneal Topography (Test group & Control group1)(2. Corneal endothelial cell (for Safety) (Test group & Control group1))
- 8. Spectacle Wearing time (Eye Care clip) (for Control group 2 and(3))
研究者
Dr Ashvin Agarwal
Dr. Agarwals Eye Hospital