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CTRI Number  CTRI/2015/07/005976 [Registered on: 07/07/2015] Trial Registered Prospectively
Last Modified On: 24/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A Clinical Trial to Study the Effectiveness and Safety of Brinzolamide 10 mg plus Timolol Maleate 5mg Ophthalmic Suspension compared with Dorzolamide 20mg plus Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open-Angle Glaucoma or Ocular Hypertension 
Scientific Title of Study   A Clinical Trial to Study the Efficacy, Safety and Tolerability of Brinzolamide 10 mg in Combination with Timolol Maleate 5mg Ophthalmic Suspension Vs. Dorzolamide 20mg plus 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;Version no.:3.0 dated 24.11.2014   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gautam Bhaduri 
Designation  Director 
Affiliation  Regional Institute of Ophthalmology,Medical College  
Address  Room Number 1, Ground Floor, Ophthalmology Department Regional Institute of Ophthalmology, Medical College 88 College Feet, Kolkata 73

Kolkata
WEST BENGAL
700073
India 
Phone  09831021798  
Fax  033-22123773  
Email  dr.gautambhaduri@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh Singh 
Designation  Vice President R&D and Reg. Affairs  
Affiliation  Ajanta Pharma Ltd  
Address  Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West

Mumbai
MAHARASHTRA
400067
India 
Phone  022-6062111  
Fax  022-6061200  
Email  shailesh.singh@ajantapharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailesh Singh 
Designation  Vice President R&D and Reg. Affairs  
Affiliation  Ajanta Pharma Ltd  
Address  Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West

Mumbai
MAHARASHTRA
400067
India 
Phone  022-6062111  
Fax  022-6061200  
Email  shailesh.singh@ajantapharma.com  
 
Source of Monetary or Material Support  
Ajanta Pharma limited 
 
Primary Sponsor  
Name  Ajanta Pharma Ltd  
Address  Ajanta Pharma Ltd, Advent 43 AB/44CD, 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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tarkeshwar Rao  Dr. R.S.P.R. Government Regional Eye Hospital  3rd Unit, Opp. Bulliya College, Resavapuvanipalem, Viskhapatnam - 530013, Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH 		 9441873644

tarakeye@gmail.com 
Dr Pramod Kumar  King George Medical University  Department of Ophthalmology, South Wing, 1st Floor, King George Medical University Chowk, Lucknow-226003, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 9838894091

pramodkumar2020@rediffmail.com 
Dr Malavika Krishnaswamy  M.S Ramaiah Medical College  M.S Ramaiah Medical College and Hospital,Banglore-560054,Karnataka
Bangalore
KARNATAKA 		 080-22183009

krishnaswamymalavika@yahoo.co.in 
Dr Gautam Bhaduri  Regional Institute Of Ophthalmology  Room no. 101, ground floor Medical College, 88, college street, Kolkata - 700073
Kolkata
WEST BENGAL 		 09831021798

dr.gautambhaduri@yahoo.in 
Dr Suvarna Gokhale  Shashwat Hospital  Shashwat Hospital. 22,Happy Colony, Kothrud, Kothrud, Pune-411038
Pune
MAHARASHTRA 		 9823408964

suvarna.gokhale@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee , M S Ramaiah Medical College and Hospitals  Submittted/Under Review 
Ethics Committee Shashwat Hospital  Submittted/Under Review 
Institutional Ethics Committee, King George’s Medical College  Submittted/Under Review 
Institutional Ethics Committee,King George Hospital  Approved 
Institutional Ethics Committee,Regional Institute of Ophthalmology, Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H401||Open-angle glaucoma, Open-Angle Glaucoma or Ocular Hypertension,  
 
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 12 weeks 
Comparator Agent  Dorzolamide 20mg plus Timolol Maleate 5mg eye drops  One drop in the affected eye(s) twice daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient having clinical diagnosis of ocular hypertension.
2.Freshly diagnosed patients of open angle glaucoma or ocular hypertension, Patients who are previously diagnosed and on treatment for open angle glaucoma or ocular hypertension will undergo washout period, Meiotic (7 days), Alpha Agonist and Alpha/beta agonist (14 days),β antagonist and prostaglandin analogs (28 days).
3.Subject with History of discontinued Carbonic anhydrase inhibitor of 2 months back.
4.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
 
 
ExclusionCriteria 
Details  1.Ocular trauma or intraocular surgery within the past 6 months.
2.Ocular infection, inflammation, or laser surgery within the past 3 months.
3.Chronic, recurrent or severe inflammatory eye disease
4.Central cornea thickness 620 mm, as measured by pachymetry, in either eye
5.Shaffer angle grade less than 2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, more thab 20]), as measured by Gonioscopy.
6.Severe central visual field loss in either eye measured by Perimetry.
7.Clinically significant or progressive retinal disease.
8.Best-corrected visual acuity worse than 0.6 logMAR (Best Corrected VA score worse than 55 ETDRS letters (20/80 Snellen equivalent))
9.Other ocular pathology (including severe dry eye) that may preclude the administration of an alpha-adrenergic agonist and/or a topical CAI.
10.A history of hypersensitivity to brinzolamide and other sulphonamides, timolol, or any other component of the medication.
11.Patients suffering from bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
12.Patients suffering from sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
13.Patients suffering from severe allergic rhinitis and bronchial hyperreactivity.
14.Patients suffering from severe renal impairment (see Hepatic / Renal Impairment).
15.Patients who have participated in other clinical studies within 3 months.
16.Any condition which are likely to hinder the compliance with the protocol.
17.Patients should not take other topical or oral beta-blockers during the study period.
18.Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
19.Patients who are scheduled to undergo surgery of the opposite eye during the study period.
20.Patients who are required to wear contact lens during the study period.
21.Significant visual field loss or evidence of progressive visual field loss within the last year.
22.Patients with recent use of high-dose (1 gm daily) salicylate therapy
23.Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
24.Cup/disc ratio greater than 0.80
25.History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitablefor the study.
26.Systemic administration of corticosteroids or immunosuppressive agents and local injection of corticosteroids in the eyes.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
IOP (Intraocular pressure) Measurement by Goldmann Applanation Tonometry   Day 1, 2nd week, 6th week, 9th week, 12th week  
 
Secondary Outcome  
Outcome  TimePoints 
Eye pain, Eye redness, multicolored halos and headache will be graded by four point scale by the physician   Day 1, 2nd week, 6th week, 9th week, 12th week 
 
Target Sample Size   Total Sample Size="232"
Sample Size from India="232" 
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)   24/07/2015 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publication 
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, Double blind, Parallel group and Multicentric clinical Study to Evaluate the Efficacy, Safety and Tolerability of Brinzolamide 10 -mg in Combination with Timolol Maleate 5mg Ophthalmic Suspension Vs. Dorzolamide 20mg plus Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open-Angle Glaucoma or Ocular Hypertension. The Study is proposed to start on 12.06.15. The following primary outcome will be measured at Day 1,at the end of 2nd, 6th, 9th and 12th week of treatment for clinical assessment: IOP (Intraocular pressure) Measurement by Goldmann Applanation Tonometry will be used as primary efficacy parameter. The secondary outcome will be measured as Eye pain, Eye redness, multicolored halos and headache will be graded and Safety assessments included solicited and unsolicited adverse events, corrected distance visual acuity, slit-lamp biomicroscopy, pachymetry, automated perimetry, fundus parameters, and resting pulse and blood pressure.

 
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