A Randomized, Double-blind, Placebo-controlled, Three-arm Clinical Study to Evaluate the Modulatory Effect of Lutein Zeaxanthin 164 Supplementation on Eye Fatigue as well as Dry Eyes in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
Eye fatigue, also known as asthenopia or computer vision syndrome (CVS), and dry eye syndrome, or keratoconjunctivitis sicca, are ocular conditions often associated with prolonged visual tasks, particularly digital screen use (>4 hours/day). Eye fatigue is characterized by eye strain, discomfort, blurred vision, double vision, and headaches, driven by reduced blink rates and environmental factors such as low humidity. Dry eye syndrome involves insufficient tear production or poor tear quality, leading to dryness, irritation, a gritty sensation, redness, and intermittent blurred vision, resulting from tear film instability. Eye fatigue and dry eye syndrome, if persistent, can lead to several complications that impact ocular health and overall well-being. Prolonged eye fatigue may result in chronic eye strain, worsening visual discomfort, and reduced visual acuity, potentially contributing to headaches and decreased productivity. Dry eye syndrome, characterized by tear film instability, can cause corneal irritation, superficial punctate keratitis, or, in severe cases, corneal abrasions, increasing the risk of ocular infections. Prolonged screen exposure has become a routine part of modern life, leading to a rise in symptoms such as eye fatigue and dry eyes. These symptoms are especially common in individuals who use digital devices for extended periods each day. Factors such as reduced blink rate, prolonged visual focus, and environmental stressors contribute to discomfort, visual strain, and tear film instability. While lubricating eye drops offer temporary relief, they do not address underlying causes like oxidative stress or light- induced damage. Nutritional supplementation, particularly with Lutein and Zeaxanthin, has emerged as a promising approach. These carotenoids are known to filter blue light and reduce oxidative stress in the eye, supporting visual performance and ocular comfort and Existing evidence supports the role of Lutein and Zeaxanthin in improving contrast sensitivity, glare tolerance, and visual processing
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy Volunteers 2.Volunteers of either sex, with age 18 to 65 years 3.Those who use the monitor for more than 4 hours/day 4.Those who can use glasses without lenses of 1.0 diopter or more 5.Eye fatigue: Slight to Moderate (using VAS-F questionnaire).
排除标准
- •Medication Use: 1.People with drug addiction 2.People who regularly use ophthalmic eye drops 3.People who use artificial tears more than 7 times per day 4.People taking medications that may affect dry eye symptoms, such as: Treatments for autoimmune diseases or thyroid disorders, Antihistamines, Beta-blockers, Tricyclic antidepressants, Estrogen therapy 5.People undergoing hormone replacement therapy B.
- •Disease Conditions: 6.People diagnosed with dry eye syndrome 7.People with chronic diseases 8.People with Sjogren’s syndrome 9.People with a history of eye surgery 10.People with other ophthalmic diseases besides dry eye syndrome, including those undergoing retinal surgery or retinal laser treatment 11.People with pollen allergies or chronic asthma 12.People with Meibomian gland dysfunction 13.People with uncontrolled hypertension SBP greater than 140 mmHg or DBP greater than 90 mmHg 14.People with uncontrolled diabetes HbA1c greater than 7.0 percent.
- •15.People with rheumatoid arthritis 16.People with sleep disorders C.
- •Other General Conditions (Physiological, Lifestyle, Allergic Reactions, etc.) 17.Contact lens users who wear lenses more than 3 days per week 18.Pregnant or breastfeeding women, or those planning to become pregnant 19.People with known allergies or adverse reactions to the investigational product 20.People with excessive alcohol consumption- Men greater than or equal to 40 g per day and Women greater than or equal to 20g per day, According to WHO daily alcohol intake guidelines 21.Heavy smokers- greater than or equal to 20 cigarettes per day 22.People who regularly take supplements or health functional foods 23.People who have taken functional foods related to eye health within the past 3 months 24.People who have participated in another clinical trial within the past 3 months 25.People deemed unsuitable for the study by the investigator’s judgment.
研究者
Dr M Dakshayini
The Oxford Medical College, Hospital and Research Centre