Efficacy and safety for the combination of lutein, vitamin C, zeaxanthin, zinc, copper, and vitamin E in Indian patients of age-related macular degeneration - Post marketing surveillance study

Abstract

Age-related macular degeneration (AMD) is an ocular disease of complex nature which reduces the quality of life of the patient. Objectives behind the conduct of this study was to evaluate the efficacy as well as safety for the combination of Lutein, Vitamin C, Zeaxanthin, Zinc, Copper and Vitamin E in patients of AMD.For the study 660 patients were recruited and 627 patients completed the study throughout India at 44 clinical trial sites. The study duration was of 90 days and efficacy and safety assessment was made on day 45 (visit 2) and day 90 (visit 3). Efficacy assessment was made by 2 efficacy assessment parameters including, “vision related quality of life (VRQOL)” and “vision Impairment score” obtained using “Vision Impairment Questionnaire”. Safety assessment was made by adverse events reported by the patients.At baseline visit, the mean VRQOL score of all the patients completed the study was 5.733 which was increased to 6.682 on visit 2 and 7.476 on visit 3 where, percentage increase was of 16.550% and 30.403% respectively on visit 2 and 3 as compared to baseline. At baseline visit, the vision impairment score was 21.389 reduced to 17.352 on day 45 and further reduced to 14.135 on day 90.Fixed dose combination of Vitamin C 250mg, Zinc 40mg, Lutein 5mg, Zeaxanthin 1mg, Copper 1mg and Vitamin E 200 IU per capsule was found efficacious and safe for the medical management of AMD in Indian patients.