CTRI/2025/07/090887尚未招募不适用
A Randomized, Double Blind, Two-Arm, Multi-centric, Placebo-Controlled Study to Evaluate the Effectiveness and Safety of Test Product on Macular Pigment Optical Density in Adult Subjects.
AK Biolink Co Ltd3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- To assess the effect of products on Macular Pigment Optical Density (MPOD) using IDEVision MPS II
研究概览
简要总结
This is a randomized, double blind, two-arm, multi-centric, placebo-controlled study to evaluate the effectiveness and safety of the test product on Macular Pigment Optical Density in adult subjects.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo ophthalmological assessment. Safety will be assessed throughout the study by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with MPOD levels between 0.2 – 0.
- •Subjects with best correction visual acuity better than 20 of 200 for each enrolled eye.
- •Female subjects of childbearing potential must have a negative serum pregnancy test performed at screening visit.
- •Subjects’ complete blood count parameters (RBC, WBC, Platelets, Differential Leukocyte count, Hb, PCV) to be within clinically acceptable range by Investigator.
排除标准
- •Pregnant or lactating women and women who are planning to get pregnant, or less than six months post-partum.
- •Subjects having other ocular pathologies e.g. glaucoma or age-related macular degeneration as assessed by the Investigator.
- •Subjects having systemic diseases like renal disorder, hepatic disorder, diabetes mellitus, hypercholesterolemia.
- •Subjects who are taking medicines or supplements (including supplements for Macular Degeneration) that affect the study.
- •Subjects with wet Exudative AMD (age related macular degeneration) in at least one eye.
- •Subjects with signs of exudative changes including subretinal fluid, pigment epithelial detachment, or hemorrhage in the retina.
- •Subjects with myopia of 6 diopters or more.
结局指标
主要结局
To assess the effect of products on Macular Pigment Optical Density (MPOD) using IDEVision MPS II
时间窗: Day 00, Day 60, Day 120 and Day 180
次要结局
- To assess the effect of products on Outer Nuclear Layer (ONL) Thickness, Retinal Pigment Epithelium (RPE) Layer Thickness and Central macular Thickness (CMT) and Central Foveal Thickness (CFT) using Optical Coherence Tomography (OCT)(Day 00, Day 60, Day 120 and Day 180)
- To assess the effect of products on visual acuity using a standardized chart (Snellen chart).(Day 00, Day 60, Day 120 and Day 180)
- To assess the effect of products on vision field measured using Perimetry.(Day 00, Day 60, Day 120 and Day 180)
- Safety Assessments (ECG, Hematological and Biochemical Blood parameters, Urine parameters)(Screening and at the end of the study)
研究者
Dr Parth Joshi
Cliantha Research
研究点 (3)
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