Abstract :
Background: 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.
Materials and Methods: 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.
Results: 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
Conclusion: 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.
Keyword :
Vitamin C, Vitamin E, Lutein, Zeaxanthin, Zinc, Copper, Astaxanthin, L-Glutathione, Efficacy and safety.