CTRI/2025/11/097648 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On:
11/02/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A clinical trail to reduce elevated Intraocular Pressure (IOP) in adult participants with Open Angle Glaucoma or Ocular Hypertension to evaluate the Safety, Tolerability and Efficacy of of Brinzolamide Brimonidine Tartrate and Timolol Ophthalmic Suspension
Scientific Title of Study
A Multicentric, Open-label, Prospective Non-comparative Active Post Marketing Surveillance Study to evaluate the Safety Tolerability and Efficacy of Fixed Dose Combination of
Brinzolamide 10 mg, Brimonidine Tartrate 2 mg and Timolol 5
mg Ophthalmic Suspension to reduce elevated Intraocular
Pressure (IOP) in adult participants with Open Angle Glaucoma
or Ocular Hypertension for whom monotherapy or dual therapy
provides insufficient IOP reduction
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
APL-CT-25-01; Version No 01; Version Date 23-Jul-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mohita Sharma
Designation
Principal Investigator
Affiliation
Tirupati Eye Centre and Research Institute
Address
Tirupati Eye Centre and Research Institute, Department of Ophthalmology, OPD Room No.01, 1st Floor Block-C, 53C, Sector-33, Near NTPC Township, Noida - 201301, Uttar Pradesh, India.
Gautam Buddha Nagar UTTAR PRADESH 201301 India
Phone
9560889495
Fax
Email
drmohita@tirupatieye.org
Details of Contact Person Scientific Query
Name
Dr Neeta Nargundkar
Designation
Director Biosphere Clinical Research Pvt. Ltd.
Affiliation
Biosphere Clinical Research Pvt Ltd
Address
Biosphere Clinical Research Pvt Ltd Office No 02 03 04 Second Floor Highland Corporate Center Kapurbawdi Junction Thane West 400607 Maharashtra India
Thane MAHARASHTRA 400607 India
Phone
9029025200
Fax
Email
drneeta@biospherecro.com
Details of Contact Person Public Query
Name
Dr Neeta Nargundkar
Designation
Director Biosphere Clinical Research Pvt. Ltd.
Affiliation
Biosphere Clinical Research Pvt Ltd
Address
Biosphere Clinical Research Pvt Ltd Office No 02 03 04 Second Floor Highland Corporate Center Kapurbawdi Junction Thane West 400607 Maharashtra India
Thane MAHARASHTRA 400607 India
Phone
9029025200
Fax
Email
drneeta@biospherecro.com
Source of Monetary or Material Support
M/S Ajanta Pharma Limited Plot No. 43AB & 44BCD, Charkop Industrial Estate, Charkop, Kandivali (W),Mumbai 400 067, Maharashtra, India.
Primary Sponsor
Name
Ajanta Pharma Limited
Address
Plot No 43 AB and 44 BCD Govt Industrial Estate Charkop Kandivali West Mumbai 400067
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 Sandeep Patil
Belagavi Institute of Medical Sciences
Department of ophthalmology, B unit, Room no- 38 ground floor, Dr. B R Ambedkar Road, Sadashiv Nagar, Belagavi – 590001, Karnataka, India. Bangalore KARNATAKA
91 9945447572
drsandeepatil@gmail.com
Dr Prashanth C N
Dr. B. R. Ambedkar Medical College and Hospital
Department of Ophthalmology, Room no- 301, 3 rd floor, Shampura Main Road, Kadugondanahalli, Bangalore - 560045, Karnataka, India Bangalore KARNATAKA
91 9880708204
prashanthcndoctor@gmail.com
Dr Vepa Meenakshi
Dr. R. S. P. R Govt Regional Eye Hospital
Department of Ophthalmology, Room no- 101, 1st floor, Andhra medical college, Opposite Bullayya College,
Resapuvanipalem, Visakhapatnam-
530013, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
91 9849123310
meenakshivepa@gmail.com
Dr P Seshu Babu
Government General Hospital Old RIMSGGH
Department of
Ophthalmology
OPD No 16 1st
Floor Government
Medical College,
Srikakulam
532001 Andhra
Pradesh India Srikakulam ANDHRA PRADESH
8942279033
bioexperts21@gmail.com
Dr Bhagat Purvi Raj
M & J Western Regional Institute of Ophthalmology,
Department of Ophthalmology, Room no.- 101 , 1st floor, B. J. Medical College, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India. Ahmadabad GUJARAT
91 9825985265
dr.purvibhagat@yahoo.com
Dr Swati R
Mysore Medical College and Research Institute, K R Hospital
Department of Ophthalmology, OPD no. 01 Ground floor , Irwin Road, Mysuru 570001, Karnataka India Mysore KARNATAKA
91 9448787598
swatiprakash.darpan@gmail.com
Dr Shreyangsi Biswas
N.R.S. Medical College and Hospital
Department of Ophthalmology, room no- 201, 2 nd floor, 138, A.J.C Bose Road Kolkata-700014, West Bengal, India. Kolkata WEST BENGAL
91 9830692465
Bshreyansi.93@gmail.com
Dr Kishore Tulsidas Pahuja
Natasha Eye Care & Research Centre
Department of ophthalmology, 2nd floor room no. 1, Pimple saudagar Shiv Sai Lane Building A Sai Saheb Society Oppo Lotus Hospital Pune 411027 Maharashtra India Pune MAHARASHTRA
91 9890086862
kishorepahuja@gmail.com
Dr Rajesh Babubhai Shah
Sanjivani Eye Hospital and Phaco Center,
Department of Ophthalmology, room no-203, basement, Satved Complex, Near
Valu’s Hospital, Near Golden
triangle, Naranpura, Ahmedabad -380013, Gujarat, India. Ahmadabad GUJARAT
91 9824024764
drrajeshshahcr@gmail.com
Dr Mohita Sharma
Tirupati Eye Centre and Research Institute
Department of ophthalmology, OPD room no. 01, 1st floor Block-C, 53C, Sector-33, Near NTPC Township, Noida - 201301, Uttar Pradesh, India. Gautam Buddha Nagar UTTAR PRADESH
Committee BIMS Belagavi Institute of Medical Sciences, Belagavi Dr B R Ambedkar Road Belgaum
Approved
Dr B R Ambedkar Medical College and Hospital Dr B R Ambedkar Medical College and Hospital No 24 Shampura Main Road, Kadugondanahalli Bengaluru, Karnataka 560045,Bangalore
Submittted/Under Review
Ethics Committee N.R.S. Medical College, NRS Medical College and Hospital NRS Medical College, 138 A.J.C Bose Road, Kolkata Kolkata- 700014, West Bengal,
Approved
Ethics Committee of Navneet Memorial Hospital Navneet Memorial Hospital, Opp. Sardar Patel Seva Samaj Hall, Navrangpura, Ahmedabad
Approved
IEC King George hospital, King George hospital Maharanipeta, Collector office Junction, Visakhapatnam Visakhapatnam -530002, Andhra Pradesh
Approved
IEC-MMC and RI and Associated Hospital, Mysore Medical College and Research Institute, Mysore Medical College and Research Institute Irwin Road, Mysuru, karnataka
Approved
Institutional Ethics Committee - B. J. Medical College and Civil Hospital B. J. Medical College and Civil Hospital Office of Medical Superintendent Civil Hospital Ahmedabad Gujarat
Skinovate Independent Ethics Committee Skinovate Laser and Cosmetic Surgery Center
Approved
Womenophthalmologists Society Independent Ethics Committee for Tirupati Eye Centre and Research Institute, Block-C, 53C, Sector-33, Near NTPC Township, Noida - 201301, Uttar Pradesh, India.
Approved
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
As this is an open label, non comparative, active PMS study, comparator agent is not applicable.
As this is an open label, non comparative, active PMS study, comparator agent is not applicable.
Intervention
Fixed Dose Combination of Brinzolamide 10 mg, Brimonidine Tartrate 2 mg and Timolol 5 mg Ophthalmic Suspension
One drop of fixed dose combination of Brinzolamide 10 mg, Brimonidine Tartrate 2 mg and Timolol 5 mg Ophthalmic Suspension to be
administered in the affected eye(s), twice daily, in the morning and evening, preferably at the same time for 12 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Adult male and female participants more 18 to less then 75 years of age.
2. Diagnosed with unilateral or bilateral open angle glaucoma (including pseudo
exfoliation or pigment dispersion) or ocular hypertension.
3. Participants who are already on monotherapy or dual drug therapy on any of the
following anti-glaucoma drugs, Timolol (0.5 percent), Brimonidine (0.1 or 0.2 percent),
Brinzolamide (1 percent) or Dorzolamide (2 percent) eye drops with IOP of 22-32 mmHg in at least
one eye.
4. Best Corrected Visual Acuity (BCVA) of 6 by 24 or better in study eye(s).
5. Gonioscopy angle more then grade 2 on Shaffer grading in the study eye(s).
6. Participants who are willing to give informed consent for participation in the study and
willing to adhere to all protocol procedures.
ExclusionCriteria
Details
1. Participants with a known history of hypersensitivity to the study
medications or any of the ingredients of the formulation.
2. Clinically significant or progressive retinal disease (i.e. retinal
degeneration, diabetic retinopathy, retinal detachment or retinal tears)
or optic nerve disease.
3. Ocular laser surgery within 3 months prior to entry.
4. Any intraocular surgery (e.g, cataract surgery) within 6 months prior
to entry.
5. Corneal abnormalities that could preclude accurate IOP readings with
tonometry.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. The assessment of the safety of participants [Based on the incidence of treatment-emergent adverse event (TEAE)].
2. The assessment of the tolerability of the study drug will be based on the incidence of AEs and SAEs.
12 weeks
Secondary Outcome
Outcome
TimePoints
1. Change from baseline in the mean IOP at Visit 3/Week 2/Day 14±2, Visit 4/Week 6/Day 42±2 and Visit 5/Week 12/Day 84±2.
12 weeks
Target Sample Size
Total Sample Size="230" Sample Size from India="230" 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 4
Date of First Enrollment (India)
02/12/2025
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="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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
Subjects will be screened on day -3 and if qualify as per the inclusion and exclusion criteria, then will consider for enrollment. the subjects will be provided with study drug and drug dosing card at enrollment visit (Day 1), which need to be brought along with in each subsequent visit till the last visit. Follow-up visits after enrollment into the study will be done on Day 14±2, Day 42±2 and the final visit at Day 84±2 of treatment to assess safety, tolerability and efficacy