None listed
Conditions
Interventions
Intervention1: Lutein and Zeaxanthin 20 mg: Dose :500mg,Doasge form:Capusle, Duration 90 days, 1 capsule per day in the morning with breakfast.
Intervention2: Lutein and Zeaxanthin 40 mg: Dose :500mg,
Sponsors
Nutrione
Dr H N Shivaprasad
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: A. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: 1.Tear production by Schirmer s test 2.Improvement in tear film stability, measured by tear film break up time (TFBUT) 3.Improvement in visual fatigue, assessed by Flicker Test Timepoint: Day 0, Day 45 , Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome: 1.To assess the safety of Lutein Zeaxanthin 164 through safety assessments like, hematology, and biochemistry (LFT and RFT) (Screening and Day 90) 2.Reduction in Subjective Symptoms evaluated using a visual analog scale (VAS) for dryness, irritation, and discomfort 3.Ocular Surface Disease Index (OSDI) Score 4.Change in eye fatigue levels by CVS Score 5.Change in eye fatigue levels VAS-F Assessment 6.Changes in Lutein and Zeaxanthin plasma concentrations Timepoint: Day 0, Day 45 , Day 90 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed