CTRI/2024/07/071413 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On:
29/07/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To determine effifacy and safety of generic brinzolamide ophthalmic suspension compared with
AZOPT ® in subjects with open-angle glaucoma or ocular hypertension.
Scientific Title of Study
A Randomized, Double-masked, Active Controlled, Parallel Group, Two-arm, Multi Center,
in-vivo Bioequivalence Study with Clinical Endpoint Comparing Brinzolamide Ophthalmic
Suspension, USP 1 Percent of Riconpharma LLC, USA to AZOPT® (Brinzolamide Ophthalmic
Suspension) 1 Percent of Novartis Pharmaceuticals Corporation, USA in subjects with Chronic Open
Angle Glaucoma or Ocular Hypertension in both eyes
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
G7SYN/P-002/2023; v01; 10-07-2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
Managing director room/first floor, contract Research Oraganization,
No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post
Bangalore Karnataka Bangalore KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Details of Contact Person Scientific Query
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
Managing director room/first floor, contract Research Oraganization,
No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post
Bangalore Karnataka
KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Details of Contact Person Public Query
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
Managing director room/first floor, contract Research Oraganization,
No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post
Bangalore Karnataka
KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Source of Monetary or Material Support
Riconpharma LLC
100 Ford Road, Suite 9,
Denville, NJ 07834,
USA.
Primary Sponsor
Name
Riconpharma LLC
Address
M/S Riconpharma LLC,
100 Ford Road, Suite 9,
Denville, NJ 07834,
USA
Advance Retina Care, Department of Opthalmology, 4th floor, 404-405, Aagam Avenue, Nr. Adani CNG Pump, Opp, Motera BRTS Stop, Sabarmati- Visat Highway, Motera-380005, India. Ahmadabad GUJARAT
9428154491
drruchimehts2012@gmail.com
Dr Ajay Kartik Ambade
Ambade Eye Hospital
Ambade Eye Hospital, Department of Opthalmology, 1st Floor, Kamla Tower, Near Jaswant Talkies, Indora Chowk, Kamptee Road, Nagpur-440002, Maharashtra, India. Nagpur MAHARASHTRA
9168631193
dr_ajayambade@rediffmail.com
Dr Rajesh Parekh
Bhagwan Mahaveer Jain Hospital
Bhagwan Mahaveer Jain Hospital, Department of Ophtalmology, Room No-1010,Millers Road, Vasanth Nagar Bangalore-560052, India. Bangalore KARNATAKA
9945544744
vision6by6@gmail.com
Dr Kaivan Kritikumar Shah
Bhavna Super speciality Eye care
Bhavna Super speciality Eye care, Department of Ophtalmology,2nd Floor, Room No- 201-204, Sundaram Space, Opposite Old Subjail, Ring Road, Surat, Gujarat 395002, India. Surat GUJARAT
9428185725
kaivanshah247@gmail.com
Dr D Lional Raj
Dr. Agarwals eye Hospital Limited
Dr. Agarwals eye Hospital Limited, Department of Ophtalmology, Room No. 15, South Bypass Road, Vannarpettai, Tirunelveli – 627003, Tamil Nadu, India Tirunelveli TAMIL NADU
462-2501818
drlionalraj@dragarwal.com
Dr Sugepriya
Dr. Agarwals eye Hospital Limited
Dr. Agarwals eye Hospital Limited, Department of Ophtalmology, 2nd floor, Room no -219, TT Krishnamachari Rd, near Raj Park Hotel, Alwarpet, Chennai, Tamil Nadu 600018, India. Chennai TAMIL NADU
9677082432
drsuge87@gmail.com
Dr Prashanth CN
Dr.B.R. Ambedkar Medical College & Hospital
Dr. B.R. Ambedkar Medical College & Hospital, Department of Opthalmology, 1st floor ,Shampura Main Road, Kadugondanahalli, Bangalore – 560045, Karnataka, India. Bangalore KARNATAKA
9880708204
prashanthcndoctor@gmail.com
Dr Tarakeshwara Rao Attada
Gayatri Vidya Parishad Institute of health care and Medical Technology
Gayatri Vidya Parishad Institute of health care and Medical Technology, Department of Ophtalmology, Maridi Valley, marika valasa, Visakhapatnam, Andhra Pradesh, 530048, India. Visakhapatnam ANDHRA PRADESH
9441873644
tarakeye@gmail.com
Dr Soumya H V
JSS Hospital
JSS Hospital, Department of Ophtalmology, 1st foor, Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004, India.
Mysore KARNATAKA
9448116151
drhvsoumya@gmail.com
DrSatish K
KR Hospital
KR Hospital, Attached to Mysore Medical College and research institute,Dermatology OPD, 1st Floor, Room No- 14, Irwin Road - 570001, Mysuru, Karnataka, India. Mysore KARNATAKA
9886400414
drsatishkeshav@gmail.com
Dr Kishore Tulsidas Pahuja
Natasha Eye care and Research Centre
Natasha Eye care and Research Centre, Department of Opthalmology, 1st Floor, Room No- 01 Sai Saheb society,Building A, Opp Vasant Avenue, Shiv Sai Lane, Pimpale Saudagar, Pune-411027, Maharashtra, India. Pune MAHARASHTRA
9890086862
kishorepahuja@gmail.com
Dr Shanbhag Nita Umesh
Omkar eye care microsurgery & Laser Center
Omkar eye care microsurgery & Laser Center, Ground floor, 302, 303 Koteshwar Plaza June of RHB Rd & Nerul Rd, Mulund (W), Mumbai- 400080, Maharashtra, India. Mumbai MAHARASHTRA
9322402424
Nita.eye@gmail.com
Dr Chetan Pankaj Saoji
Shalinitai Meghe Hospital & Research Centre
Shalinitai Meghe Hospital and Research Centre, Department of Opthalmology, 1 Floor, Wanadongri, Hingna Road, Nagpur-441110, Maharashtra, India. Nagpur MAHARASHTRA
Institutional Ethics Committee Gayatri Vidya Parishad Institute of Health Care
Approved
Institutional Ethics Committee of Aayush Hospital , Aayush Hospital
Approved
Institutional Ethics Committee, AKHMC
Approved
Institutional Ethics Committee,JSS Medical College
Approved
Niramaya Hospital Ethics Committee
Submittted/Under Review
Nirmal Hospital Ethics Committee , (BAVANA)
Approved
Riddhi Medical Nursing Home IEC
Approved
SMHRC Ethics Committee
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, (2) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Azopt® (Brinzolamide Ophthalmic Suspension) 1%
Subjects shall be instructed to use their assigned Investigational Product at home starting from Day 1 (Next day of Visit 2 - Baseline/Randomization Visit) for 42 consecutive days (6 weeks) except the morning dose (8.00 AM) of Day 14 and Day 42, which shall be instilled at the clinical site. Subjects shall be instructed to shake the bottle well and then instill Investigational Product into the inferior cul-de-sac of both eyes (OU) at 8.00 a.m. (±60 minutes), 4.00 p.m. (±60 minutes) and 10.00 p.m. (±60 minutes).
Intervention
Brinzolamide Ophthalmic Suspension, USP 1%
Subjects shall be instructed to use their assigned Investigational Product at home starting from Day 1 (Next day of Visit 2 - Baseline/Randomization Visit) for 42 consecutive days (6 weeks) except the morning dose (8.00 AM) of Day 14 and Day 42, which shall be instilled at the clinical site. Subjects shall be instructed to shake the bottle well and then instill Investigational Product into the inferior cul-de-sac of both eyes (OU) at 8.00 a.m. (±60 minutes), 4.00 p.m. (±60 minutes) and 10.00 p.m. (±60 minutes).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male or non-pregnant female aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes.
2. Subject requires treatment of both eyes and is able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
3. Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
4. Subject has the best spectacle-corrected visual acuity (BSCVA) equivalent to 20/200 or better in each eye.
5. Adequate wash-out period prior to the baseline of any ocular hypotensive medication. To minimize potential risk to the subject due to intraocular pressure (IOP) elevations during the washout period, the investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandins; however, the subject must have discontinued all ocular hypotensive medication for the minimum washout period provided in the table below;
Medication Minimum Washout Period
Parasympathomimetics (e.g., pilocarpine, carbachol) 4 days
Carbonic anhydrase inhibitors (systemic or topical) (e.g., acetazolamide, dorzolamide hydrochloride, and brinzolamide) 4 days
Sympathomimetics (e.g., dipivefrin, and epinephrine) 2 weeks (14 days)
Alpha-agonists (e.g., apraclonidine, brimonidine tartrate, brimonidine tartrate/brinzolamide) 2 weeks (14 days)
Beta-adrenergic blocking agents (e.g., timolol, timolol maleate, dorzolamide hydrochloride, timolol maleate and brimonidine tartrate, levobunolol, betaxolol, metipranolol, carteolol) 4 weeks (28 days)
Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost, and tafluprost) 4 weeks (28 days)
6. Subject are willing and able to provide written informed consent before any study procedures are performed.
7. Subject willing and able to understand and comply with the requirements of the study, consume the Investigational Product as instructed, return at the appropriate scheduled visits, comply with therapy prohibitions, and be able to complete the study.
8. Female subject of childbearing potential practicing an approved method of contraception and willing to continue its use from study entry to the end of the study and have a negative Urine Pregnancy Test at the time of screening
or
Female subject of non-childbearing potential.
9. Male subjects must use accepted methods of birth control or must agree to practice abstinence from study entry to the end of the study
ExclusionCriteria
Details
1. Subject with angle closure glaucoma.
2. Females who are pregnant, breastfeeding, or planning a pregnancy.
3. Female of childbearing potential who do not agree to utilize an adequate form of contraception.
4. Current or past history of severe hepatic or renal impairment.
5. Current or history within 2 months before baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
6. Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
7. Patients with severe central visual field loss in either eye; severe central visual field loss was defined as a sensitivity of less than or equal to 10dB in at least 2 of the 4 visual field test points closest to the point of fixation.
8. Corneal thickness more than600 µm in either eye.
9. History of severe dry eye in either eye.
10. Subjects with known or suspected drug or alcohol abuse.
11. Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy.
12. Use at any time before the baseline of intraocular corticosteroid implant.
13. Use within 1 week before the baseline of contact lens.
14. Use within two weeks before baseline of 1) topical ophthalmic corticosteroid or 2) topical corticosteroid.
15. Use within one month before baseline of 1) systemic corticosteroid or 2) high-dose salicylate therapy.
16. Use within six months before baseline of intravitreal or subtenon injection of ophthalmic corticosteroid.
17. Having undergone within 6 months before baseline any other intraocular surgery (e.g., cataract surgery, LASIK).
18. Having undergone within 12 months before baseline refractive surgery, filtering surgery, or laser surgery for IOP reduction.
19. Participating in a clinical study or therapy with an Investigational Product within the past 30 days.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
The mean difference in Intraocular Pressure (IOP) of both eyes between the treatment groups at four point at 08:00 AM ± 30 minutes and at 10:00 AM ± 30 minutes using the Goldmann applanation tonometer at the baseline visit (Visit 2) and at Day 14 (Week 2) and Day 42 (Week 6) visits.
Total Sample Size="660" Sample Size from India="660" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Sponsor is developing a generic version of Brinzolamide Ophthalmic Suspension, USP 1%. The proposed study is designed in compliance with the current product specific guidance published by the Office of Generic Drugs (OGD), US FDA to establish bioequivalence for the sponsor’s Brinzolamide Ophthalmic Suspension, USP 1% compared to AZOPT® (Brinzolamide Ophthalmic Suspension) 1% of Novartis Pharmaceuticals Corporation USA.
This is a randomized, double-masked, active controlled, parallel group, two-arm, multi center, in-vivo bioequivalence study with clinical endpoint comparing Brinzolamide Ophthalmic Suspension, USP 1% of Riconpharma LLC, USA to AZOPT® (Brinzolamide Ophthalmic Suspension) 1% of Novartis Pharmaceuticals Corporation, USA in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.