Post-marketing surveillance study to compare the efficacy and safety by investigating the combination of Vitamin C, Vitamin E, Lutein, Zeaxanthin, Zinc and Copper with the combination of Astaxanthin, L-Glutathione and Lutein (contains Zeaxanthin) in patients of dry age-related macular degeneration (AMD)

Abstract

To determine the comparative efficacy and safety of Investigational Product – 1 (combination of Vitamin C, Vitamin E, Lutein, Zeaxanthin, Zinc and Copper) with Investigational product 2 (combination of Astaxanthin, L-Glutathione and Lutein (contains Zeaxanthin)) in patients for the indication of dry age-related macular degeneration (AMD). It was an academic, prospective, open labelled, parallel, randomized, multicentric, comparative post-marketing surveillance study. The study was conducted at 5 clinical trial sites with 40 patients at each site. Patients with confirmed diagnosis of dry AMD in right or left or both eyes who met study inclusion and exclusion criteria were recruited for the study. The study duration was of 365 days and during the same patients were asked to visit the clinical trial site on day 30, 180 and 365 for the safety and efficacy assessment. Visual acuity, vision related quality of life and visual impairment questionnaire were the efficacy assessment parameters evaluated. Total 181 patients completed the study. It was found that there was statistically significant difference in the patients treated with the investigational product 1 and 2 for the efficacy assessment parameter, visual acuity (p value 0.0102) and vision related quality of life (p value 0.0013) and for visual impairment questionnaire score, no statistically significant difference was found (p value 0.0747). Investigational product 1 was found to be more efficacious as compared to investigational product 2 for the efficacy assessment parameters visual acuity and vision related quality of life. Whereas for visual impairment questionnaire score i.e. vision required for the daily work, both products were found to be equally efficient.