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CTRI Number  CTRI/2022/04/042021 [Registered on: 21/04/2022] Trial Registered Prospectively
Last Modified On: 28/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to Evaluate efficacy and safety of Fixed Dose Combination of Brinzolamide plus Brimonidine Ophthalmic Suspension compared to Brinzolamide Ophthalmic Suspension plus Brimonidine Tartrate Ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension. 
Scientific Title of Study   A Multi-Center,Open-Label, Randomized,Active Controlled, Comparative,Parallel-Group, Phase III Clinical Study to Evaluate the efficacy and safety of FDC of Brinzolamide 1% w/v plus Brimonidine 0.1% w/v IP Ophthalmic Suspension versus Brinzolamide Ophthalmic Suspension 1% w/v plus Brimonidine Tartrate Ophthalmic solution 0.1% w/v in patients with Primary open-angle glaucoma or ocular hypertension. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BRPL/CT/FDC/BNZBR/05/21; Version 3.0; dated 07.12.2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main RBI, Layout JP Nagar Phase 7, Bangalore

Bangalore
KARNATAKA
560061
India 
Phone  091-9811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main RBI, Layout JP Nagar Phase 7, Bangalore

Bangalore
KARNATAKA
560061
India 
Phone  091-9811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main RBI, Layout JP Nagar Phase 7, Bangalore

East
KARNATAKA
560061
India 
Phone  091-9811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
Akums Drugs Pharmaceuticals Limited,Plot No. 131 to 133, Block –C, Mangolpuri Industrial Area, Phase -1 (Adjoining CBSE Office), New Delhi - 110083. 
 
Primary Sponsor  
Name  Akums Drugs Pharmaceuticals Limited 
Address  Plot No. 131 to 133, Block –C, Mangolpuri Industrial Area, Phase -1 (Adjoining CBSE Office), New Delhi - 110083. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikumbh Usha Subhash  B.J. Govt. Medical College and Sasson General Hospital  Opd No.- 69, 1st floor Department of Opthalmology, Pune
Pune
MAHARASHTRA 		 8446974945

dr.ushanikumbh@yahoo.com 
Dr Parul Singh  G S V M Medical College  Department of Ophthalmology GSVM Medical College, Swaroop Nagar Kanpur
Kanpur Nagar
UTTAR PRADESH 		 08009537183

parulsingh1406@gmail.com 
Dr T Jyothirmayi  Government of Medical College and Government General Hospital  Department of Ophthalmology, Government of Medical College and Government General Hospital, Srikakulam 532001
Srikakulam
ANDHRA PRADESH 		 8942179033

drjyothirmayi.ggh@gmail.com 
Dr Suvendu Das  Life Line Diagnostics Center Cum Nursing Home  Department of Ophthalmology, 4A, Wood Street, Kolkata
Kolkata
WEST BENGAL 		 9433933175

drsuvendudas@gmail.com 
Dr Sanjeev Taneja  Maharaja Agrasen Hospital  Department of Ophthalmology, Block C, Shivaji Park, West Punjabi Bagh,
West
DELHI 		 09810452835

sjtaneja@gmail.com 
Dr Rajiv Kumar Gupta  Rajendra Institute of Medical Sciences (RIMS)  Department of Ophthalmology, Bariatu, Ranchi-834009,
Ranchi
JHARKHAND 		 9431168169

rajiv.gupta08@rediffmail.com 
Dr Rajesh Parekh  Sajeevani Netralaya  Glaucoma Division, 141, INFANTRY ROAD, OPPOSITE THE HINDI NEWSPAPER, BENGALURU
Bangalore
KARNATAKA 		 080-41204067

vision6by6@gmail.com 
Dr Charudatta Kalamkar  Shree Ganesh Vinayak Eye Hospital  Glaucoma Department, Dhamtari Rd, Pachpedi Naka, Raipur
Raipur
CHHATTISGARH 		 07714077741

charudutt03@yahoo.co.in 
Dr Jayanta Kuila  Sunayan Advanced Eye Institute  Station Road, Salgechia, Tamluk, Purba Medinipur 721636
Medinipur
WEST BENGAL 		 9163686495

dr.jkuila@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College  Approved 
IEC of B.J.G.M.C and Sassoon General Hospital  Approved 
Institutional Ethics Committee Shree Ganesh Vinayak Eye Hospital  Approved 
Institutional Ethics committee, Life LINE Diagnostics center cum Nursing Home  Approved 
Institutional Ethics Committee, Rajendra Institute of Medical Sciences (RIMS)  Submittted/Under Review 
Institutional Ethics Committee,  Government of Medical College and Government General Hospital,  Approved 
Institutional Ethics Committee, Sunayan Advanced Eye Institute  Approved 
Maharaja Agrasen Hospital Institutional Ethics Committee  Approved 
Muktai Hospital Ethics Committee  Approved 
SRI DURGAMBA INDEPENDENT ETHICS COMMITTEE  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Brinzolamide Ophthalmic Suspension 1% w/v plus Brimonidine Tartrate Ophthalmic solution 0.1% w/v  The recommended dosage is one drop of Brinzolamide Ophthalmic Suspension 1% w/v and Brimonidine Tartrate Ophthalmic solution 0.1% w/v individually in the affected eyes twice daily (Preferably at Morning and Night) with at least 10 minutes apart. Treatment Duration : 84 Days 
Intervention  FDC Brinzolamide 1% w/v plus Brimonidine 0.1% w/v IP Ophthalmic Suspension   The recommended dosage is one drop of FDC of Brinzolamide 1% w/v plus Brimonidine 0.1% w/v IP Ophthalmic Suspension of twice daily (Preferably in Morning and Night) in the affected eyes. Treatment Duration : 84 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male and non-pregnant, non-lactating female subjects between 18 to 75 years of age
(both inclusive).
2. Patients diagnosed with Open-angle glaucoma or ocular hypertension who were
insufficiently controlled on monotherapy or being treated with multiple IOP-lowering
medications.
Note: Patients will undergo washout period as follows: miotics and oral or topical
carbonic anhydrase for 4 days; α- agonists and α/β agonists for 14 days; β-antagonists
and prostaglandin analogues for 28 days.
3. Patients with 0-hour IOP of ≥ 24 - ≤ 36 mm Hg and 2-hour IOP of ≥ 21 - ≤ 36 mm of
affected eye(s).
4. Patients with mean IOP ≤ 36 mm Hg in both eyes at all time points.
5. Patients with best corrected visual acuity equivalent to 20/200 or better in each eye.
6. Female Patients, of child-bearing potential practicing an acceptable method of birth
control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-
barrier method, transdermal, injection or implants, non-hormonal or hormonal,
condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal
suppository; for the duration of the study as judged by the investigator(s)/study
physician and agree to follow the same should be used during treatment.
OR
Postmenopausal for at least 1 year.
OR
Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has
been performed on the Subject).
7. Patients who are able to understand and give voluntary, written informed consent to
participate in this clinical investigation and from whom written consent has been
obtained.
8. Patients shall be willing and able to understand and comply with the requirements of
the study, administer the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions and be able to complete the study. 
 
ExclusionCriteria 
Details  1. Documented history of hypersensitivity to either of the study medications or any of the
ingredients of the formulation.
2. Patients with Schaffer angle grade < 2 in either eye (as measured by gonioscopy).
3. Patients with cup-to disc ratio > 0.80 (horizontal or vertical measurement) in either
eye.
4. Patients with severe central visual field loss (i.e., sensitivity ≤ 10 dB in ≥ 2 of the 4
visual field test points closest to the point of fixation) in either eye.
5. Patients with history of chronic, recurrent, or current severe inflammatory eye disease
(i.e., scleritis, uveitis, herpes keratitis) in either eye.
6. Patients with documented history of ocular trauma ≤ 6 months before the study.
7. Patients with documented history of clinically significant or progressive retinal disease
(e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye.
8. Patients with documented history of intraocular surgery ≤ 6 months before the study.
9. Patients with documented history of cataract or corneal ulcer.
10. Patients who are unable to safely discontinue IOP-lowering ocular medications.
11. Patients with documented history of ocular laser surgery ≤ 3 months before the study.
12. Patients with one eye.
13. Patients with any abnormality preventing reliable applanation tonometry.
14. Patients with severe illness or other condition that would make the patient unsuitable
for the study, as per investigator discretion.
15. Patients with active or prior severe, unstable, or uncontrolled cardiovascular,
cerebrovascular, hepatic, or renal disease that would prevent safe administration of
topical alpha-adrenergic agonists or carbonic anhydrase inhibitors, as per investigator
discretion.
16. Patients with use of topical ophthalmic corticosteroid or topical corticosteroid within
two weeks prior to baseline visit.
17. Patients with use of intraocular corticosteroid implant at any time prior to baseline
visit.
18. Patients with use of systemic corticosteroids, high-dose salicylate therapy, monoamine
oxidase inhibitors therapy, any antidepressant which affects noradrenergic
transmission (eg, tricyclic antidepressants, mianserin) and adrenergic-augmenting
psychotropic drug (eg, desipramine, amitriptyline) within one month prior to baseline
visit.
19. Patients with clinically significant laboratory abnormalities at the time of screening.
20. Changes in systemic medication within 30 days prior to screening that could have a
substantial impact on IOP, or anticipated changes during the study.
21. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
22. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
23. Patients who have a recent history or who are currently known to abuse alcohol or
drugs.
24. Patients who have been treated with an investigational drug or investigational device
within a period of 4 weeks prior to study entry.
25. Female Patients who are pregnant or lactating or planning to become pregnant during
the study period.
26. Female Patients who are not ready to use acceptable contraceptive methods during
the course of study.
27. Female Patients with positive urine pregnancy test at screening.
28. Suspected inability or unwillingness to comply with the protocol or other study
procedures. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in mean IOP from baseline.   Baseline, week 4, week 8 and week
12 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in 0-hour time point IOP from baseline.   Baseline, week 4,
week 8 and week 12 
Mean change in 2-hour time point IOP from baseline.   Baseline, week 4,
week 8 and week 12 
Percentage of patients with target IOP (≤ 21mmHg)   12 weeks 
Change in the mean value of Morisky medication adherence scale between two groups.   12 weeks 
Proportion of patients with incidence of at least one adverse event.  Week 12 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   30/04/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a Phase III, open label, randomized, multicenter, active controlled, parallel-group, two arm comparative study. The study will be conducted at approximately 12-15 number of centers in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval.

After the informed consent process,  completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. Demographics, Medical and surgical history shall be recorded during screening visit. Details of concomitant medications and adverse events if any shall be recorded during each visit. Physical examination (including general and systemic examinations) shall be done during screening and each successive visit. Vital signs shall be measured on each visit. Laboratory assessment and Urine Examination hall be performed on screening and week 12/ end of study visit. ECG will be performed at screening visit.

Ocular Assessments (visual acuity, slit-lamp examination, dilated fundus examination and gonioscopy) will be performed at each visit. Perimetry will be performed at screening and end of study visit. At randomization/baseline visit, subjects shall be randomly (open label) assigned in 1:1 fashion to one of the two treatment groups. ubjects shall be instructed to administer one drop of FDC of Brinzolamide 1% w/v plus Brimonidine 0.1% w/v IP Ophthalmic 
Suspension of test drug twice daily (Preferably at Morning and Night) in the affected eyes or one drop of comparator drug (Brinzolamide Ophthalmic Suspension 1% w/v and Brimonidine Tartrate Ophthalmic solution 0.1% w/v individually in the affected eyes twice daily (Preferably at Morning and Night) with at least 10 minutes apart, for 12 weeks of treatment duration. 
 
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