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CTRI Number  CTRI/2021/08/035406 [Registered on: 04/08/2021] Trial Registered Prospectively
Last Modified On: 04/05/2023
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparative post marketing surveillance study to compare the efficacy and safety for the combination of Vitamin C, Vitamin E, Lutein, Zeaxanthin, Zinc and copper with the combination of Astaxanthin, L-Glutathione and Lutein (contains Zeaxanthin) in the patients of Age-related macular degeneration. 
Scientific Title of Study   A prospective, open labelled, parallel, multicentric, comparative post marketing surveillance study to compare the efficacy and safety of AREDS 2 formula, the combination of Vitamin C, Vitamin E, Lutein, Zeaxanthin, Zinc and copper with the combination of Astaxanthin, L-Glutathione and Lutein (contains Zeaxanthin) in the patients of Age-related macular degeneration (AMD). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lalit Jeevan Pawaskar 
Designation  Executive Pharmacovigilance (overall trial coordinator), Centaur Pharmaceuticals Pvt Ltd. 
Affiliation  Centaur Pharmaceuticals Pvt Ltd 
Address  Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, India.

Mumbai (Suburban)
MAHARASHTRA
400 055
India 
Phone  8793725153  
Fax    
Email  lalit@centaurlab.com  
 
Details of Contact Person
Scientific Query  
Name  Lalit Jeevan Pawaskar 
Designation  Executive Pharmacovigilance (overall trial coordinator), Centaur Pharmaceuticals Pvt Ltd. 
Affiliation  Centaur Pharmaceuticals Pvt Ltd 
Address  Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, India.

Mumbai (Suburban)
MAHARASHTRA
400 055
India 
Phone  8793725153  
Fax    
Email  lalit@centaurlab.com  
 
Details of Contact Person
Public Query  
Name  Lalit Jeevan Pawaskar 
Designation  Executive Pharmacovigilance (overall trial coordinator), Centaur Pharmaceuticals Pvt Ltd. 
Affiliation  Centaur Pharmaceuticals Pvt Ltd 
Address  Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, India.

Mumbai (Suburban)
MAHARASHTRA
400 055
India 
Phone  8793725153  
Fax    
Email  lalit@centaurlab.com  
 
Source of Monetary or Material Support  
Centaur Pharmaceuticals Pvt Ltd Centaur House, Shanti Nagar, near Grand Hyatt, Vakola, Santacruz East, Mumbai, Maharashtra 400055 
 
Primary Sponsor  
Name  Centaur Pharmaceuticals Pvt Ltd 
Address  Centaur House, Shanti Nagar, near Grand Hyatt, Vakola, Santacruz East, Mumbai, Maharashtra 400055 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bapat Siddhesh Vishwanath   Allcure superspeciality hospital   AllCure Superspeciality hospital, Kesar Plaza, Gufa road/ Station road, Jogeshwari east.
Mumbai
MAHARASHTRA 		 9930925424

drsiddheshretina@gmail.com 
Dr Hitesh Mulchand Cheda  Asian eye institute and laser centre pvt ltd   Asian eye institute and laser centre pvt ltd , Plot 10 A, Satyanrayan apartment, opp. G.H.high school, off. M.G road, Borivali (east), mumbai - 400066
Mumbai
MAHARASHTRA 		 02228940598

asianeyehospital@gmail.com 
Dr Bhavesh J Gohil  Dadar Eye and Gynaec Centre   Dadar eye and gynaec centre, Prabhat view, B-wing, L.N road, opp. swami narayan temple, near dadar station east, mumbai- 400014
Mumbai
MAHARASHTRA 		 022-24113344

clearvision247@gmail.com 
Dr Sameer D Sawant  Samarth eye care and laser centre  Samarth eye care and laser centre, aurum enclave, 1st floor, nehru road, near P and T colony, vakola masjid, santacruz (east), mumbai- 400055
Mumbai
MAHARASHTRA 		 02226656060

sawantsameer@yahoo.co.in 
Dr Aniruddha D Mahindrakar  V Care Eye Clinic  V care eye clinic,601,6th floor, Centre square building, opp. nadco shopping complex, S.V Road, Andheri (west), mumbai 400058
Mumbai
MAHARASHTRA 		 02226207247

aniruddhamahindrakar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Suraksha - Ethics committee   Approved 
Suraksha - Ethics committee   Approved 
Suraksha - Ethics committee   Approved 
Suraksha - Ethics committee   Approved 
Suraksha - Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H353||Degeneration of macula and posterior pole,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Investigational product 1  Each capsule contains combination of Vitamin C 250 mg, Zinc 40 mg, Lutein 5 mg, Zeaxanthin 1 mg, Copper 1 mg and Vitamin E 200 IU. 
Comparator Agent  Investigational product 2  Each tablet contains combination of Astaxanthin 6 mg, L-Glutathione 5 mg and Lutein (contains Zeaxanthin 256 mcg) 3.2 mg. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Age: 50 years and above
2. Genders: both Males and Females
3. Patients eye (right or left or both) with confirmed diagnosis of nonexudative AMD with following drusen characteristics associated with high risk of progression to exudative AMD.
3.1 Soft type drusen
3.2 More than 5 drusen
3.3 Drusen size greater than 63 µm
3.4 Confluence of drusen (≥1)
3.5 Retinal pigment epithelium hyperpigmentation
4. Patients must be able to swallow capsules/tablet with the help of water
5. Best correction visual acuity better than 20/200 for each enrolled eye
6. Patients agreed to stop current use of supplements containing Vitamin C, Zinc, Lutein, Zeaxanthin, Copper, Vitamin E, Astaxanthin or Glutathione other than investigational product 1 or 2
7. Willing to sign on informed consent form
8. Patients who can adhere to the study protocol for the study duration. 
 
ExclusionCriteria 
Details  1. Patients with exudative AMD in the recruited eye.
2. Any retinal pathology other than AMD.
3. Previous intravitreal injection, seizure disorder and cataract
4. Patient with ocular or systemic medication known to be toxic to the lens, retina or optic nerve.
5. Patient with history of diabetic retinopathy or presence of vitreous haemorrhage or retinal detachment or macular hole.
6. A chronic requirement for any systemic or ocular medication administered for other disease and known to be toxic to retina or optic nerve.
7. IOP ≥26 mmHg (Participant might have glaucoma)
8. Cataract surgery within 3 months.
9. Previous daily supplementation with 2 mg or more Lutein for period of 1 year or more prior to date of randomization.
10. Patients with Hemochromatosis.
11. Patients with Wilson’s disease recent diagnosis of oxalate kidney stones.
12. Patients known to be hypersensitive to any of the excipient of the investigational products.
13. Patients who cannot adhere to the Protocol (Mentally Ill and Patients with Psychological problem)
14. Any disease with a poor 1 year survival prognosis.
15. Pregnant or lactating woman. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 

i. Visual acuity test.
 		 Day 0, 180 and 365 
 
Secondary Outcome  
Outcome  TimePoints 
i. Vision Impairment Questionnaire
ii. Vision related quality of life 		 Day 0, 180 and 365 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="350" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   10/08/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Study shall be published in a scientific journal after its completion at all clinical trial sites. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 This is a a post marketing surveillance study to compare the efficacy and safety for the investigational product 1 and 2. Investigational product 1 is AREDS 2 formula, each capsule contains combination of Vitamin C 250 mg, Zinc 40 mg, Lutein 5 mg, Zeaxanthin 1 mg, Copper 1 mg and Vitamin E 200 IU. Each tablet of Investigational Product 2 contains combination of Astaxanthin 6 mg, L-Glutathione 5 mg and Lutein (contains Zeaxanthin 256 mcg) 3.2 mg. The clinical trial duration is of 365 days.
 
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