None listed
Conditions
Interventions
Intervention1: Lutein(10 mg) & Zeaxanthin (2 mg/day): Identical, brown-colored, soft gelatin capsule containing Lutein
(10 mg) & Zeaxanthin (2 mg/day) long with standard of care, 1 capsule for 6 month
Sponsors
Star Hi Herbs PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged 20 to 65 years old 2. BMI: 20 to 30kg/m2 3. Corrected eyesight is higher than 20/60 during eyesight testing (corrected visual acuity) 4. The subjects who have MPOD level between 0.2to 0.4 and those without any severe eye diseases. 5. The subjects who doesn’t have any problem on eye accommodation 6. The subjects who has drusen corresponding to early AMD (category 2) of AREDS 7. Subjects willing to comply with the prescribed treatment regimen for the duration of study participation. 8. No Known metabolic diseases or gastrointestina disorders and no known cognitive decline 9. No anticipated changes in dieting habits (as relevant to xanthophyll intake). 10. No anticipated surgical procedures. 11. Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements. 12. The subject is willing to complete all the study procedures including study-related tasks, and comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects with the complete vision loss 2. Subjects who are allergic to the study drug 3. Subjects suffering from severe or uncontrolled systemic or metabolic diseases. 4. Pregnant, lactating woman, or planning to become prenant. 5. Subjects who are taking any other medicine which interact with the study drug during the treatment 6. Subjects with severe concurrent illness (cardiovascular, renal, hepatic), and with any other condition that in the opinion of the investigator does not justify the inclusion of the subject in the study. 7. Subject whose lifestyle (including diet and food intake) would, in the Investigator’s judgment affect the subject’s participation in the study. 8. Subjects who have participated in any other clinical trial in the past 30 days from the study start. 9. Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study. 10. Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls. 11. Subjects with hyperlipidemia ( >6.2 mmol/L) 12. Ophthalmic patients other than AMD, retinal surgery and retinal laser treatment 13. Subjects with macular atrophy 14. Those with signs of exudative changes, including subretinal retinal fluid, pigmented epithelial detachment or bleeding 15. Subjects with 6 diopter and above myopia factors 16. Subjects with a cloudy cataract or cornea 17. Subjects who are taking hyperlipidemia control agents, controlled diets and a hormone replacement 18. Current use of xanthophyll containing supplements 19. Use of xanthophyll containing supplements in the past 6 months 20. Participation in any other study during last 3 month. 21. Blood donation during the last 3 months. 22. Known hypersensitivity or allergy to xanthophylls. 23. Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes. 24. Suspected lack of compliance with any requirements of the study. 25. Any relevant abnormalities in the routine laboratory tests 26. Smokers 27. Alcoholics 28. The subjects who are already undergoing the medications such as Lutein, Zeaxanthin, Omega3 29. The subjects who are on Beta-carotene, Astaxanthin, Anthocyanin, multi-vitamins, treatment with Retinal which is the form of Vitamin A-aldehyde, 30. The subjects taking the products of Functional ingredients that may help to eye health such as Bilberry extract, Haematococcus extract, Zeaxanthin extract, Lutein compound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in macular pigment optical density (MPOD) 2. Lutein & Zeaxanthin amount in the bloodTimepoint: 1. Change in macular pigment optical density (MPOD) at Day 1, Day 90, 180. 2. Lutein & Zeaxanthin amount in the blood at Day 0, Day 90, Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in glare disability & discomfort 2. Change in speeding photo stress recovery 3. Change in extending visual range 4. To measure improvement in chromatic contrastTimepoint: Baseline (Visit 1) to Day 90, 180 | — |
Countries
India
Contacts
Public ContactDr C T SADASHIVA
Department of Pharmacy Practice, Head Clinical Trials,Clinical Trial Centre
Outcome results
None listed