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CTRI Number  CTRI/2018/04/013091 [Registered on: 06/04/2018] Trial Registered Prospectively
Last Modified On: 12/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial to check the effect, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in patients with Ocular Hypertension / Glaucoma 
Scientific Title of Study   A Comparative, Randomized, Two Arm, Double Blind, Parallel group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in Subjects Suffering from Ocular Hypertension / Glaucoma.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
APL/CT/15/06 Version No.02, Oct 19, 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B Kantha Sree 
Designation  Principal Investigator  
Affiliation  Gandhi Hospital 
Address  Musheerabad Secunderabad Telangana

Hyderabad
ANDHRA PRADESH
500003
India 
Phone  9618888684  
Fax    
Email  kanthasreebagge@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh Singh 
Designation  Sr Vice President R&D and Regulatory Affairs 
Affiliation  Ajanta Pharma Limited  
Address  Ajanta Pharma Ltd Advent 43 AB/44 BCD Charkop Industrial Estate Kandivali West Mumbai Maharashtra

Mumbai
MAHARASHTRA
400067
India 
Phone  2266062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailesh Singh 
Designation  Sr Vice President R&D and Regulatory Affairs 
Affiliation  Ajanta Pharma Limited  
Address  Ajanta Pharma Ltd Advent 43 AB/44 BCD Charkop Industrial Estate Kandivali West Mumbai Maharashtra

Mumbai
MAHARASHTRA
400067
India 
Phone  2266062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Source of Monetary or Material Support  
Ajanta Pharma Ltd, Advent 43 AB/ 44 BCD Charkop Industrial Estate Kandivali West, Mumbai Maharashtra  
 
Primary Sponsor  
Name  Ajanta Pharma Ltd 
Address  Advent 43 AB/ 44 BCD Charkop Industrial Estate Kandivali West, Mumbai Maharashtra  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 19  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganesh Venkatraman  Aravind Eye Hospital  Basement OPD, Beside Retina Department, Avinashi Road, Coimbatore-641014
Coimbatore
TAMIL NADU 		 0422-4360400

dr.ganeshvr@cbe.aravind.org 
Dr Ajay Karthik Ambade  Arneja Heart and Multispeciality Hospital  Address-123, Ramdaseth, Nagpur-440010. Maharashtra
Nashik
MAHARASHTRA 		 9823178466

dr_ajayambade@rediffmail.com 
Dr Nishit Dhoka  Bansal Hospital & Research Centre  04, Janakpuri 1st Imli Phatak, Jaipur-302005, Rajasthan.
Jaipur
RAJASTHAN 		 09660038297

nishitd@gmail.com 
Dr Nitin Batra  Christian Medical College and Hospital   Department of Ophthalmology, Brown Road, Ludhiana, Punjab-141008
Ludhiana
PUNJAB 		 9815333665

nbatra2001@gmail.com 
Dr Swati Samant  Dept. of Ophthalmology, Institute of Medical Sciences & SUM Hospital  Dept. of Ophthalmology, Institute of Medical Sciences & SUM Hospital, Kalinga Nagar, Ghatikia, Bhubaneswar-751003, Odisha.
Khordha
ORISSA 		 9439423969

swatisamantadhar@gmail.com 
Dr B Kantha Sree  Gandhi Hospital  Department of Ophthalmology, Musheerabad,Secunderabad-500003
Hyderabad
ANDHRA PRADESH 		 9618888684

bkanthasree@gmail.com 
Dr A Tarakeswara Rao  Government Regional Eye Hospital   Department of Ophthalmology, 3rd Unit, Opp. Bullaya College, Resavapuvanipalem, Visakhapatnam-530013
Visakhapatnam
ANDHRA PRADESH 		 9441873644

tarakeye@gmail.com 
Dr Nilesh V Parekh  Govt. Medical College & Sir T. Hospital  Department of Ophthalmology, Nr. State Road Transport Corporatioon Bus Stand, Bhavnagar 364001
Bhavnagar
GUJARAT 		 9825252673

drnvparekh@hotmail.com 
Dr Shalini Mohan  GSVM Medical College  Department of Ophthalmology, Swaroop Nagar, Kanpur-208002, UP. India
Kanpur Nagar
UTTAR PRADESH 		 9506740966

drshalinimohan@gmail.com 
Dr Naresh Desinayak  JPM Rotary Club of Cuttack Eye Hospital   JPM Rotary Club of Cuttack Eye Hospital & Research Institute, CDA, Sector-VI, Cuttack, Odisha, Pin 753014
Cuttack
ORISSA 		 9438017918

ndesinayak@yahoo.co.in 
Dr Vijaya Pai H  Kasturba Medical College & Hospital   Department of Ophthalmology, Madhav Nagar, Manipal-576104
Udupi
KARNATAKA 		 9845426427

paivijaya@yahoo.co.in 
Dr Pramod Kumar   King George’s Medical University  Department of Ophthalmology,South Wing, 1st Floor, King George’s Medical University, Lucknow- 226003
Lucknow
UTTAR PRADESH 		 9838894091

Pramodkumar2020@rediffmail.com 
Dr Daxa Pande  Medilink Hospital Research Centre  Basement Medilink Hospital, Nr. Shyamal Cross Road, 132 ft. Ring Road, Satellite, Ahmedabad – 380015, Gujarat
Ahmadabad
GUJARAT 		 08347457660

daxajay_108@yahoo.com 
Dr V Dinesh Kanth  Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital  Department of Ophthalmology,Ground Floor, Srikakulam-532001
Srikakulam
ANDHRA PRADESH 		 8500949101

dkmedico17@gmail.com 
Dr Rudro Prosad Ghosh  Regional Institute of Ophthalmology   Room No.101, Ground Floor, Medical College, 88, College Street, Kolkata-700073
Kolkata
WEST BENGAL 		 9830821049

docrpg2000@yahoo.com 
Dr Vikas Kanaujia  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Department of Ophthalmology, Raebareli road, Lucknow-226014
Lucknow
UTTAR PRADESH 		 0522-2494736

kanaujia@sgpgi.ac.in 
Dr Tinku Bali Razdan  Sir Ganga Ram Hospital  OPD No. F1, Rajinder Nagar, New Delhi, Delhi 110060
New Delhi
DELHI 		 9999901122

tinkubali2020@yahoo.com 
Dr Radha Annamalai  Sri Ramachandra Hospital  Hospital No. 1,Ophthalmology Department, Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU 		 04445928699

srmcinnovis@gmail.com 
Dr Nilay Kumar Majumdar  Susrut Eye Foundation & Research Centre  HB-36/A/1 Sector III, Salt Lake City, Kolkata 700106
Kolkata
WEST BENGAL 		 9830219381

dr5nemo765@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 19  
Name of Committee  Approval Status 
Arneja Institutional Ethics Committee  Approved 
Ethics committee Government Medical College Bhavnagar  Approved 
Ethics Committee GSVM Medical College  Approved 
Ethics Committee Rajiv Gandhi & RIMS  Approved 
Ethics Committee, Sir Ganga Ram Hospital Ethics Committee  Submittted/Under Review 
Ethics Committee, Susrut Eye Foundation & Research Centre  Approved 
Institutional Ethics Committee Aravind Medical Research Foundation  Submittted/Under Review 
Institutional Ethics Committee CMC Ludhiana  Submittted/Under Review 
Institutional Ethics Committee Gandhi Medical College  Approved 
Institutional Ethics Committee Institute of Medical Sciences (IMS) and SUM Hospital  Approved 
Institutional Ethics Committee King George Hospital Lucknow  Approved 
Institutional Ethics Committee King George Hospital Vishakhapatnam  Submittted/Under Review 
Institutional Ethics Committee Regional institute of Ophthalmology  Submittted/Under Review 
Institutional Ethics Committee SGPGI  Approved 
Institutional Ethics Committee Sri Ramachandra University  Submittted/Under Review 
Institutional Ethics Committee, Bansal Hospital and Research Centre  Approved 
Institutional ethics Committee, JPM Rotary Club of Cuttack Eye Hospital and Research Institute  Approved 
Manipal University Ethics Committe Kasturba Hospital  Submittted/Under Review 
Medilink Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Ocular Hypertension/Glaucoma, (1) ICD-10 Condition: H408||Other glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v  Instill one drop in the affected eye twice daily for 90 days  
Comparator Agent  Timolol Maleate Eye Drops 0.5% w/v   Instill one drop into the affected eye twice daily for 90 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subjects with IOP between 22mm Hg – 30mm Hg at the time of screening in any one eye. Incase both the eyes of a single subject are affected then the eye fulfilling the criteria will be considered for the evaluations. If both eyes are fulfilling the criteria, then the right eye will be considered for the study.
2.Voluntary willingness of patient to give written informed consent prior to participation in trial.
 
 
ExclusionCriteria 
Details  1.Women who are not using an effective means of contraception or who are pregnant or nursing.
2.Subjects with any severe or advanced cases of Glaucoma
3.Shaffer angle grade < 2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, > 20]), as measured by Gonioscopy.
4.Subjects who are blind or subjects who have a single eye.
5.Severe central visual field loss in either eye measured by Perimetry.
6.Cup/disc ratio greater than 0.80.
7.Subject who are schedule to undergo surgery of the eye during the study period.
8.History of/current chronic, recurrent or severe inflammatory eye disease (eg: scleritis, uveitis, herpes keratitis) or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.
9.History of ocular trauma or any other intraocular surgery within the past 6 months in either eye.
10.Current/history of ocular infection or inflammation within the past 3 months as determined by patient history and/or eye examination.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean reduction in the IOP from baseline to end of study visit.  Day 0 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Mean reduction in the phasing of IOP from baseline to end of study visit.   Day 0 and Day 90 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "217"
Final Enrollment numbers achieved (India)="217" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/04/2018 
Date of Study Completion (India) 06/12/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/12/2018 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is Comparative, Randomized, Two Arm, Double Blind, Parallel group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in Subjects Suffering from Ocular Hypertension / Glaucoma. The Primary Outcome of the study is Mean reduction in the IOP from baseline to end of study visit.

 
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