None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 70 high electronic screen users aged 18 to 65 years will be randomly assigned to receive capsules containing either Lute-gen (Lutein 10 mg & Zeaxanthin-isomers 2mg) daily or a placebo for 6 months. Changes in eye strain, eye fatigue, dry eye symptoms and general visual health will be assessed over time by administering several validated self-report questionnaires and objective eye assessments. Moreover, changes in sleep quality and attention will be evaluated over time.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Generally healthy adults (male and female) 18 to 65 years 2. Spends at least 6 hours a day viewing a screen at a distance of 1 metre or less 3. Non-smoker 4. BMI between 18 and 30 kg/m2 5. No plan to commence new treatments over the study period 6. Willing to maintain current diet, exercise, and supplement regimen during the study period 7. If wearing spectacles for vision, best corrected visual acuity must be 6/6 8. Understand, willing and able to comply with all study procedures 9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. Ocular disorders including but not limited to cataract, corneal diseases, ocular surface disorders, glaucoma, retinal disease, and myopia (except mild to moderate severity) 2. Undergone eye surgery in the past 3. Wear contact lenses more than 3 days a week 4. Suffering from a recently diagnosed or uncontrolled medical condition including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease, gallbladder disease/gallstones/biliary disease, rheumatoid arthritis or another autoimmune disease, asthma, seasonal allergies, or endocrine disease. 5. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), or cancer/malignancy 6. Regular medication intake including but not limited to steroid medications, hormone replacement therapy, eye drops, antihistamines, beta-blockers, or tricyclic antidepressants. 7. Change in medication in the last 3 months or an expectation to change during the study duration 8. Taking vitamins, herbal, or other nutritional supplements that are reasonably expected to influence study measures. 9. Current or 12-month history of illicit drug abuse 10. Alcohol intake greater than 14 standard drinks per week 11. Women who are pregnant, breastfeeding, or intend to fall pregnant in the next 6 months 12. Any significant surgeries over the last year 13. Planned major lifestyle change in the next 6 months
Outcome results
None listed