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CTRI Number  CTRI/2012/04/002609 [Registered on: 27/04/2012] Trial Registered Prospectively
Last Modified On: 22/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical Trial in patients suffering from open angle glaucoma or ocular hypertension. This clinical trial is to study effect, safety and tolerability of Brinzolamide + Timolol Ophthalmic Suspension (test product) in comparison to Dorzolamide plus Timolol Maleate (reference product)eye drops. 
Scientific Title of Study   "A Clinical trial to study the efficacy, safety and tolerability of Brinzolamide 10 mg in combination with Timolol 5 mg Ophthalmic suspension vs Dorzolamide 20mg + Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open Angle Glaucoma or Ocular Hypertension” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
APL/CT/10/051, V1, 13/01/2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailesh Singh  
Designation  Associate Vice President DRA and R&D  
Affiliation  Ajanta Pharma Ltd, Advent  
Address  Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India

Mumbai
MAHARASHTRA
400 067
India 
Phone  022-66062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh Singh  
Designation  Associate Vice President DRA and R&D  
Affiliation  Ajanta Pharma Ltd, Advent  
Address  Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India


MAHARASHTRA
400 067
India 
Phone  022-66062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailesh Singh  
Designation  Associate Vice President DRA and R&D  
Affiliation  Ajanta Pharma Ltd, Advent  
Address  Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India


MAHARASHTRA
400 067
India 
Phone  022-66062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Source of Monetary or Material Support  
Ajanta Pharma Ltd  
 
Primary Sponsor  
Name  Ajanta Pharma Ltd  
Address  Ajanta Pharma Ltd, Advent 43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Navin Patel  Dhatri Eye Hospital  Dhatri Eye Hospital, Opp. Mela Ground, Vadipara Chowk, Surendranagar – 363001
Surendranagar
GUJARAT 		 9426857373

patel_navin@hotmail.com 
Dr Prashant Mahajan  Omkar Eye Care Center  Omkar Eye Care Center, 101, Bldg. No. 6, Ostwal Paradise, Opp. Shivar Garden, Mira-Bhyander Road, Mira Road (E), Thane – 401107
Thane
MAHARASHTRA 		 9869117630

prashant_sm11@rediffmail.com 
Dr Rajesh Kumar Gupta  Shantanu Netralaya  Shantanu Netralaya, 40, Deen Dayal Colony, Near Kabir Nagar, Varanasi
Varanasi
UTTAR PRADESH 		 09935442488

snetralaya@sify.com 
Dr Harsha Tripathi  Shantnam Eye Care Hospital  Shantnam Eye Care Hospital, 211, Rudra Arcade, Drive-in-Road, Helmet Char Rasta, Memnagar, Ahmedabad – 380052
Ahmadabad
GUJARAT 		 9376929075

harshatripc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Independent Ethics Committee - Aditya, Dr. Harsha Tripathi, Aditya EC, ACEAS Clinical Research, 001, Aradhya Apartments, Behind Hero-Honda Show room, Under New Shreyas Fly Over, Ambawadi, Ahmedabad 380 015, India   Approved 
Independent Ethics Committee -Aditya Dr.Navin Patel, Shantanam Eye Care Hospital, 211, Rudra Arcade, AhmedabadAditya EC, ACEAS Clinical Research, 001, Aradhya Apartments, Behind Hero-Honda Show room, Under New Shreyas Fly Over, Ambawadi, Ahmedabad 380 015, India   Approved 
Meet Ethics Committee, Dr.Prashant Mahajan,Meet EC, Maher Nursing Home, G1-2/A Shri Krishna Avenue, Shri Krishna Nagar, Borivali East, Sawar Pada Corner, Mumbai- 400 066, India  Approved 
Popular Hospital Ethics Committee, Dr.R.K.Gupta, Popular Hospital EC, D.L.W. Mahmoorganj Road, Near Kakarmtta Rly crossing, Varanasi, U.P.Pin-221004  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Open angle glaucoma or ocular hypertension, (1) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brinzolamide 10mg in combination with Timolol Maleate 5mg Ophthalmic Suspension  One drop in the conjunctival sac of the affected eye(s) twice daily for 6 weeks 
Comparator Agent  Dorzolamide 20mg + Timolol Maleate 5mg eye drops  One drop in the affected eye(s) twice daily for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Male and Female patients of age 18 years and older.
2.Patient having clinical diagnosis of ocular hypertension.
3.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
 
 
ExclusionCriteria 
Details  1.Male and Female patients of age less than 18 years.
2.A history of hypersensitivity to brinzolamide and other sulphonamides, timolol, or any other component of the medication.
3.Patients suffering from bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
4.Patients suffering from sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
5.Patients suffering from severe allergic rhinitis and bronchial hyperreactivity.
6.Patients suffering from severe renal impairment (see Hepatic / Renal Impairment).
7.Patients who have participated in other clinical studies within 3 months.
8.Any condition which are likely to hinder the compliance with the protocol.
9.Patients should not take other topical or oral beta-blockers during the study period.
10.Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
11.Eye surgery or laser treatment within 12 weeks prior to study enrollment.
12.Patients who are scheduled to undergo surgery of the opposite eye during the study period.
13.Patients who are required to wear contact lens during the study period.
14.Significant visual field loss or evidence of progressive visual field loss within the last year.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
IOP (Intraocular pressure) Measurement  Day 0, first week, third week, sixth week 
 
Secondary Outcome  
Outcome  TimePoints 
Eye pain, Eye redness, multicolored halos and headache   Day 0, first week, third week, sixth week 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 3 
Date of First Enrollment (India)   23/05/2012 
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="6"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a comparative, randomized, single blind, parallel group, and multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Tolerability of Brinzolamide 10 Mg in Combination with Timolol Maleate 5mg Ophthalmic Suspension Vs Dorzolamide 20mg + Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open Angle Glaucoma or Ocular Hypertension.The Study is proposed to start on 23 May 2012. The following primary out come will be measured at  Day 0, 1st week, 3rd week, 6th week: IOP (Intraocular pressure) Measurement. The secondary parameter will be measured at  Day 0, 1st week, 3rd week, 6th week - Eye pain, Eye redness, multicolored halos and headache. At the final visit overall response of clinical cure & overall global assessment (based on total score of signs & symptoms) will be done. 
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