Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Lutein & Zeaxanthin complex: One capsule will be administered orally after breakfast for a duration of 180 days.
Control Intervention1: Placebo: One capsule will be administered orally
Sponsors
AK Biolink Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects with MPOD levels between 0.2 0.4. 2) Subjects with best correction visual acuity better than 20 of 200 for each enrolled eye. 3) Female subjects of childbearing potential must have a negative serum pregnancy test performed at screening visit. 4) Subjects complete blood count parameters (RBC, WBC, Platelets, Differential Leukocyte count, Hb, PCV) to be within clinically acceptable range by Investigator.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women and women who are planning to get pregnant, or less than six months post-partum. 2) Subjects having other ocular pathologies e.g. glaucoma or age-related macular degeneration as assessed by the Investigator. 3) Subjects having systemic diseases like renal disorder, hepatic disorder, diabetes mellitus, hypercholesterolemia. 4) Subjects who are taking medicines or supplements (including supplements for Macular Degeneration) that affect the study. 5) Subjects with wet Exudative AMD (age related macular degeneration) in at least one eye. 6) Subjects with signs of exudative changes including subretinal fluid, pigment epithelial detachment, or hemorrhage in the retina. 7) Subjects with myopia of 6 diopters or more.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of products on Macular Pigment Optical Density (MPOD) using IDEVision MPS IITimepoint: Day 00, Day 60, Day 120 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of products on Outer Nuclear Layer (ONL) Thickness, Retinal Pigment Epithelium (RPE) Layer Thickness and Central macular Thickness (CMT) and Central Foveal Thickness (CFT) using Optical Coherence Tomography (OCT)Timepoint: Day 00, Day 60, Day 120 and Day 180;To assess the effect of products on visual acuity using a standardized chart (Snellen chart).Timepoint: Day 00, Day 60, Day 120 and Day 180;To assess the effect of products on vision field measured using Perimetry.Timepoint: Day 00, Day 60, Day 120 and Day 180;Safety Assessments (ECG, Hematological and Biochemical Blood parameters, Urine parameters)Timepoint: Screening and at the end of the study | — |
Countries
India
Contacts
Public ContactDr Parth Joshi
Cliantha Research
Outcome results
None listed