A randomized double-blind placebo-controlled clinical study for the comparative evaluation of efficacy and tolerability of XanMax® 2004 in adult subjects with dry eye symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Dry eye disease (DED), also known as dry eye syndrome (DES), is a multifactorial disorder of the ocular surface characterized by instability of the tear film, leading to symptoms of dryness, irritation, and visual disturbances. It is further associated with increased tear osmolarity and inflammation, resulting in damage to the ocular surface. The International Dry Eye Workshop (TFOS DEWS II) has defined DED as a condition of tear film instability and osmolarity, which can be classified into two primary subtypes: aqueous-deficient dry eye (ADDE), characterized by insufficient tear production, and evaporative dry eye (EDE), resulting from excessive tear evaporation, often due to meibomian gland dysfunction (MGD) or environmental factors.
To evaluate the comparative efficacy of XanMax® 2004 oral soft gel capsules (containing lutein and zeaxanthin 20 mg in the ratio of 5:1), with that of placebo soft gel capsules in adult subjects with dry eye symptoms
Building on this evidence, the present study aims to evaluate the efficacy and tolerability of XanMax® 2004, a novel formulation containing lutein and zeaxanthin, in adult subjects with dry eye symptoms. This randomized, double-blind, placebo-controlled clinical study will assess the impact of supplementation on tear film stability, tear production, and symptom alleviation, providing insights into the potential benefits of lutein and zeaxanthin in addressing the growing burden of DED.
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
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female participants aged 40 to 75 years.
- •Participants who spend at least four hours per day engaged in screen-based activities (e.g., watching television, using a computer, laptop, or other digital devices).
- •Participants reporting symptoms of dry eye, such as irritation, pain, or itching, along with vision-related symptoms such as glare.
- •Participants with a tear break-up time (TBUT) of less than 10 seconds, as measured during screening.
- •Willingness and ability to attend scheduled follow-up visits and comply with the study protocol.
- •Ability to provide written informed consent prior to participation.
排除标准
- •Diagnosis of any significant ophthalmic disease.
- •Presence of ocular conditions, including but not limited to cataracts, corneal diseases, ocular surface disorders, glaucoma, retinal diseases, or severe myopia (mild to moderate myopia is permitted).
- •History of eye surgery or regular use of contact lenses for more than three days per week.
- •Diagnosis of any recent or uncontrolled medical conditions, including but not limited to hypertension, diabetes mellitus, cardiovascular disease, gastrointestinal disorders, gallbladder disease, rheumatoid arthritis, other autoimmune diseases, endocrine disorders, or active malignancy.
- •History or diagnosis of psychiatric or neurological conditions, excluding mild to moderate depression or anxiety.
- •Regular use of medications known to affect ocular health or study outcomes, including but not limited to corticosteroids, hormone replacement therapy, antihistamines, beta-blockers, tricyclic antidepressants, or ocular medications such as eye drops.
- •Recent changes in medication regimen within the past three months or an expectation to change medications during the study period.
- •Current use of vitamins, lutein, zeaxanthin, or other supplements that may interfere with study outcomes.
- •History of illicit drug use within the past 12 months or alcohol consumption exceeding 14 standard drinks per week.
- •Pregnant or breastfeeding women or those planning to conceive within six months of the study start date.
- •History of significant surgery within the past 12 months.
- •Planned major lifestyle changes (e.g., relocation, job changes) during the study period.
- •Use of artificial tears more than seven times per day.
- •Diagnosis of Sjögren’s syndrome or any other systemic condition associated with dry eye disease.
- •Individuals working regular late-night shifts.
- •Any condition that, in the opinion of the Principal Investigator, may interfere with the participant’s ability to comply fully with the study protocol, pose a significant safety risk, or affect the interpretation of study results.
研究者
Dr P Seshu Babu
Government Medical College and Hospital (RIMS)