A comparative study in the Indian patients of geographic atrophy for the efficacy and safety for the AREDS 2 Formula, the combination of Vitamin C, Copper, Zeaxanthin, Zinc, Lutein, and Vitamin E, with the combination of L-Glutathione, Lutein (contains Zeaxanthin) and Astaxanthin

Abstract

Geographic atrophy (GA) is the main reason of blindness in people above 60 years. During this study, the efficacy and safety of two different combinations including Investigational product 1 (IP-1) combination of Vitamin C, Copper, Lutein, Zinc, Zeaxanthin, and Vitamin E vs Investigational product (IP-2) combination of Lutein (which contains Zeaxanthin), L-Glutathione and Astaxanthin was compared in for the indication of GA. On day 30, 180, and 365 all the recruited clinical trial subjects were required to visit the clinical trial site, with day 0 serving as the baseline visit. Patients assigned to IP-1 were categorized as group C patients, whereas those assigned to IP-2 were categorized as group D patients. Visual acuity (VA), vision-related quality of life (VRQOL), and the vision impairment questionnaire (VIQ) were used as efficacy assessment measures. Based on the patients' reported adverse events, a safety assessment was done.Statistically significant increase was not found in patients randomized to IP-1in VA (p=0.6229) and VRQOL (p=0.1772) and no statistically significant reduction in VIQ score (p = 0.2503). In patients randomized to IP-2, there was statistically significant increase in VA (p<0.0001), statistically significant reduction in VRQOL (p=0.0036) and no significant increase in VIQ (p=0.5993). In both groups there was statistically significant difference in VA (p=0.0134) and VRQOL (p=0.0045) and no statistically significant difference in VIQ (p=0.2787). IP-1 was more effective than IP-2 in terms of maintaining VA (p=0.0134) and VRQOL (p=0.0045), however there was no statistically significant difference in the effectiveness of the two products for VIQ (p=0.2787) in patients of GA.