FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/12/060575 [Registered on: 20/12/2023] Trial Registered Prospectively
Last Modified On: 17/01/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A post marketing surveillance study of Moxifloxacin Hydrochloride solution to check its ability to prevent the growth or spread of bacteria & its safety in patient undergoing ophthalmic surgery. 
Scientific Title of Study   A Non-randomized, Non-Interventional, Prospective, Multicenter, Post Marketing Surveillance Study to Assess the Antibacterial Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative (Preoperative and Postoperative) Sterilization in Patients Undergoing Ophthalmic Surgery 
Trial Acronym  VIGAMOX 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CUKG489C1IN01 version 01 dated 19 june 2023   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr. Anup Thorat, 
Designation  Franchise Medical Head 
Affiliation  Novartis Healthcare Private Limited.  
Address  Novartis Healthcare Private Limited. The Inspire – BKC, 7th Floor, G-Block, BKC Main Road, Bandra Kurla Complex, Bandra East Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  9702855895  
Fax    
Email  anup_vilas.thorat@novartis.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr. Anup Thorat,  
Designation  Franchise Medical Head 
Affiliation  Novartis Healthcare Private Limited. 
Address  Novartis Healthcare Private Limited. The Inspire – BKC, 7th Floor, G-Block, BKC Main Road, Bandra Kurla Complex, Bandra East Mumbai MAHARASHTRA 400051 India.

Mumbai
MAHARASHTRA
400051
India 
Phone  9702855895  
Fax    
Email  anup_vilas.thorat@novartis.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr. Anup Thorat, 
Designation  Franchise Medical Head,  
Affiliation  Novartis Healthcare Private Limited.  
Address  Novartis Healthcare Private Limited. The Inspire – BKC, 7th Floor, G-Block, BKC Main Road, Bandra Kurla Complex, Bandra East Mumbai MAHARASHTRA 400051 India.

Mumbai
MAHARASHTRA
400051
India 
Phone  9702855895  
Fax    
Email  anup_vilas.thorat@novartis.com  
 
Source of Monetary or Material Support  
Novartis Healthcare Private Limited is a sponsor of this study. As this is an observational study material support is not provided. However, study sites will be supported with monetary benefits in return of the efforts and time to conduct this observational study. Details of monetary benefits shall be included in the clinical trial agreement which shall be notified to respective ECs.  
 
Primary Sponsor  
Name  Novartis Healthcare Private Limited  
Address  M/S Novartis healthcare private limited, Inspire BKC, part of 601 and 701 BandraKurla complex, Bandra (east), Maharashtra, Mumbai 400051 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Puja Bang  AIIMS  AIIMS Tandapeth, Nagpur, Maharashtra 441108
Nagpur
MAHARASHTRA 		 9850553305

drpujabang@aiimsnagpur.edu.in 
Dr JS Titiyal  AIIMS Delhi  AIIMS Ansari Nagar, New Delhi, Delhi 110029
New Delhi
DELHI 		 011-26593101
011-26593101
titiyal@gmail.com 
Dr Gopal Pillai  Amrita Institute of Medical Sciences,  Amrita Institute of Medical Sciences, Clinical Professor and HOD Department Of Opthamology, Amrita Institute of Medical Sciences and research centre, AIMS Ponekkara P.O., Kochi Kerela 682041
Ernakulam
KERALA 		 9447391266

gopalspillai@gmail.com 
Dr Mahipal Sachdev  Centre for Sight  Centre For Sight Limited, Opposite Metro Pillar No. 628, Najafgarh Road, Vikaspuri, West Delhi, Delhi - 110018.
West
DELHI 		 92504250
011-92504250
drmahipal@gmail.com 
Dr Srinivasan Rao  Dr. Agarwals Eye Hospital Limited  Dr. Agarwals Healthcare Limited, No.06, TDK Tawor, Duraiswamy Reddy Street, West Tambaram, Chennai, 600045, Tamil Nadu India
Chennai
TAMIL NADU 		 9500001092

cheyyarrao152@yahoo.com 
Dr Jignesh Gosai  MJ Institute of Ophthalmology  MJ Institute of Ophthalmology, Department Of Opthamology, Room No. 253, Clinical Research Room, Civil Hospital Campus, Civil Hospital Road, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT 		 9824321195

dr_jigneshgosai@hotmail.com 
Dr Vandana Yadav  R.K.Netralaya Eye Hospital Pvt. Ltd.,   R.K.Netralaya Eye Hospital Pvt. Ltd., Dayal Enclave, D-63/B-10 A-1, Mahmoorganj Road, Near Ksheer Sagar Mahmoorganj, Varanasi, Uttar Pradesh 221010
Varanasi
UTTAR PRADESH 		 9560697756

vandu163@gmail.com 
Dr Aditya Sudhalkar  Raghudeep Eye Hospital   Raghudeep Eye Hospital Near Shriji Complex, Raghjudeep Eye Hospital, 1-2-3, Gurukul, Road, Memnagar, Ahmedabad, Gujarat 380052
Ahmadabad
GUJARAT 		 9909917561

dradityasudhalkar@gmail.com 
Dr Laxmikanta Mondal  Regional Institute of Ophthalmology  Regional Institute of Ophthalmology College Street 88, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL 		 9830830216

lakshmi.mondal62@gmail.com 
Dr Hari Shanker Nag  Susrut Eye Hospital  Susrut Eye Hospital HB-36/A/1, Sec.-III, Salt Lake City, Kolkata, West Bengal 700106
Kolkata
WEST BENGAL 		 9153330883

drharishankernag@susrut.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Centre for Sight Institutional Ethics Committee  Approved 
Dr. Agarwals Eye Hospital - Institutional Ethics Committee  Approved 
Ethics Committee Susrut Eye Foundation and Research Center  Approved 
G.V. Meditech Ethics Committee,  Approved 
IEC Iladevi Cataract and IOL Research Center-IEC  Approved 
Institute Ethics Committee All India Institute of Medical Sciences, Delhi  Submittted/Under Review 
Institutional Ethics Committee Amrita Institute of Medical Sciences  Approved 
INSTITUTIONAL ETHICS COMMITTEE B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL   Approved 
Institutional Ethics Committee for Clinical Trial All India Institute of Medical Sciences, Nagpur  Approved 
Institutional Ethics Committee Regional Institute of Ophthalmology,  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Moxifloxacin Hydrochloride Ophthalmic Solution 0.5%,  one drop 5 times a day 2 days prior to surgery & 3 times a day post surgery until day 14, Route- Topical Eye Drops 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Male or female patients > 18 years of age, who have been prescribed 0.5% Moxifloxacin drops preoperatively (2 days) and postoperatively for 2 weeks after ocular surgery
Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study 
 
ExclusionCriteria 
Details  Patients with known history of hypersensitivity to fluoroquinolones
Novartis Confidential Page 14
Non-Interventional Study Protocol v00 CUKG489C1IN01
Patients with history of serious underlying ocular or systemic disease or complication before surgery
Patients diagnosed with an extraocular bacterial, viral, fungal infection prior to surgery
Patients who have been administered other topical antibacterial agents within 24 hours of Moxifloxacin administration or systemic antibacterial agents within 72 hours of Moxifloxacin administration
Patients who have planned to undergo cataract surgery in both eyes on same day
Patients who have participated in another clinical study within 30 days prior to the start of this study
Pregnant women/lactating mothers/ women suspected to be pregnant 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To measure the post-op endophthalmitis infection rate  1. To measure the post-op endophthalmitis infection rate upto day fourteen 
 
Secondary Outcome  
Outcome  TimePoints 
To confirm endophthalmitis & assess clinical signs of other postoperative infections on Days 1, 7 and 14 after surgery.  Diagnosis of suspected endophthalmitis patients using microbiological culture & Gram stain of aqueous & vitreous fluids
To assess for infection using 4 clinical signs post-surgery:
a. Drop in vision
b. Pain and redness
c. Swelling
d. Purulent discharge
To assess number and proportion of patients with ocular adverse events (AEs) after surgery 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   30/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The purpose of this study is to generate additional safety and effectiveness data on 0.5 % Moxifloxacin Hydrochloride solution in Indian patients who are undergoing ophthalmic surgery that more closely resemble the real-world population intended to be treated. This study is being conducted as part of the post-marketing regulatory commitment to the Indian Health authority. 
Close