A randomized, double blind, placebo controlled, parallel study to evaluate the comparative efficacy of XanMax(R) 2004 (10mg and 20mg Lutein and Zeaxanthin) oral soft gel capsule with that of a placebo soft gel capsule in improving MPOD levels in elderly volunteers.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in MPOD levels
研究概览
简要总结
Lutein and zeaxanthin are essential components of macular health, with significant evidence supporting their role in preventing and managing AMD, cataracts, and other retinal disorders. Their supplementation represents a promising strategy for enhancing visual function and mitigating age-related visual decline, particularly in populations with low dietary intake of carotenoids. The inclusion of lutein and zeaxanthin in clinical and public health strategies has the potential to address the growing burden of visual impairment and improve quality of life in diverse populations. Given the established benefits of lutein and zeaxanthin for eye health, this study aims to evaluate the comparative efficacy of XanMax® 2004 10 mg capsule (containing lutein and zeaxanthin in 5:1 ratio), XanMax® 2004 20 mg capsule (containing lutein and zeaxanthin in 5:1 ratio) and a matching placebo capsule in improving the macular pigment optical density (MPOD) in elderly volunteers. This randomized, double-blind, placebo-controlled, parallel study will provide valuable insights into the potential synergistic effects of these compounds in promoting ocular health and preventing age-related vision impairment. The present study is designed to confirm the efficacy and safety of lutein and zeaxanthin with the study title—“A randomized, double blind, placebo controlled, parallel study to evaluate the comparative efficacy of XanMax® 2004 (10 mg and 20 mg lutein / zeaxanthin) oral soft gel capsule with that of a placebo soft gel capsule in improving MPOD levels in elderly volunteers.â€
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteers of any sex, aged 45 to 65 years.
- •Volunteers with a body mass index (BMI) between 20 and 33 kg/m².
- •Volunteers with macular pigment optical density (MPOD) levels between 0.2 and 0.
- •Volunteers with no clinically significant ocular pathological conditions (minor and clinically insignificant accommodation issues of the eyes may be included).
- •Willing and able to adhere to the dietary regimen outlined in the study protocol.
- •Willing to attend regular follow-up visits as specified in the study protocol.
- •Capable of providing written informed consent.
排除标准
- •History of hypersensitivity to herbal extracts, dietary supplements, or study related components.
- •Presence of clinically significant ocular pathologies, including but not limited to glaucoma, mature cataracts, or pan-retinal degenerations.
- •History or diagnosis of systemic diseases such as hypercholesterolemia, renal disorders, hepatic disorders, diabetes mellitus, or other debilitating conditions.
- •Current or recent treatment in the last three months with herbal or allopathic ocular medications.
- •Participation in any other clinical trial or receipt of an investigational drug within the last three months.
- •Any condition that, in the investigators judgment, would preclude safe participation in the study or compromise study results.
- •Pregnant or lactating women, women planning to conceive during the study period, or women less than six months postpartum.
- •Prior use of lutein, zeaxanthin, or other antioxidant replacement therapies within the six months preceding the study.
结局指标
主要结局
Changes in MPOD levels
时间窗: Day 0, Day 60 and Day 120
次要结局
- Safety Assessments (hematology, serum chemistry and urine analysis)(Day 0 and Day 120)
研究者
Dr Santosh Gopi Krishna G
Narayana Nethralaya