Lalit Pawaskar, Mayuresh Kiran, Amit Sharma, Mayuresh Kiran
{"title":"通过考察维生素C、维生素E、叶黄素、玉米黄质、锌和铜联合用药与虾青素、l -谷胱甘肽和叶黄素(含玉米黄质)联合用药治疗干性年龄相关性黄斑变性(AMD)的疗效和安全性的上市后监测研究","authors":"Lalit Pawaskar, Mayuresh Kiran, Amit Sharma, Mayuresh Kiran","doi":"10.18231/j.ijceo.2023.081","DOIUrl":null,"url":null,"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.","PeriodicalId":13485,"journal":{"name":"Indian Journal of Clinical and Experimental Ophthalmology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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)\",\"authors\":\"Lalit Pawaskar, Mayuresh Kiran, Amit Sharma, Mayuresh Kiran\",\"doi\":\"10.18231/j.ijceo.2023.081\",\"DOIUrl\":null,\"url\":null,\"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.\",\"PeriodicalId\":13485,\"journal\":{\"name\":\"Indian Journal of Clinical and Experimental Ophthalmology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indian Journal of Clinical and Experimental Ophthalmology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18231/j.ijceo.2023.081\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian Journal of Clinical and Experimental Ophthalmology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18231/j.ijceo.2023.081","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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)
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.