CTRI/2023/05/052720 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On:
21/06/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Safety and efficacy of Brinzolamide and Timolol eye drops to decrease intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension for whom single drug therapy provides insufficient for intraocular pressure reduction
Scientific Title of Study
A Prospective, Multi-centre, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Fixed Dose Combination of Brinzolamide and Timolol Ophthalmic Suspension to Decrease Intraocular Pressure (IOP) in Adult Patients with Open-angle Glaucoma or Ocular Hypertension for whom Monotherapy Provides Insufficient IOP Reduction
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ICR/22/002, Version No. 1.0, Dated 22/FEB/2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President & Head - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
9819767704
Fax
02243244323
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Supriya Sonowal
Designation
Senior Manager – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244323
Email
Supriya.Sonowal1@sunpharma.com
Details of Contact Person Public Query
Name
Vibhawari Waghanna
Designation
Manager-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244323
Email
vibhawari.waghanna@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited (SPLL),
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharma Laboratories Limited (SPLL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, 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 = 22
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sujata Shailendra Navare
Aster Aadhar Hospital (Prerana Hospital Ltd.)
Department of Ophthalmology, Aster Aadhar Hospital (Prerana Hospital Ltd.) 1st Floor, OPD No. 210/211
R.S No. 628, B Ward, Near KMT Workshop,
Shastri Nagar, Kolhapur, Maharashtra, India 416012
Kolhapur MAHARASHTRA
9225068511
sujatanavare.aacr@gmail.com
Dr Usha Nikumbh
B.J. Medical college and Sassoon Hospital
OPD no.61, Department of Ophthalmology, B.J.Medical college and Sassoon Hospital , Pune -411001 Pune MAHARASHTRA
8446974945
dr.ushanikumbh@yahoo.com
Dr Sumita Dahiya
D.Y. Patil Hospital
OPD-51, Department of Ophthalmology , D.Y.Patil Hospital, Sector 5 , Nerul Navi Mumbai- 400706 Mumbai (Suburban) MAHARASHTRA
9819389276
sumitakarandikar@hotmail.com
Dr Megha Ramnik Kotecha
D.Y. Patil Medical College, Hospital & Research Centre
PD number 11, Department of Ophthalmology, Dr. D.Y. Patil Medical College, Hospital & Research Centre, Pimpri, Pune -411018, Maharashtra. Pune MAHARASHTRA
Government Medical College & Government General Hospital (Old RIMSGGH)
Government Medical College & Government General Hospital (Old RIMSGGH), 1st Floor, OT no. 20, Srikakulam-532001, A.P, India. Srikakulam ANDHRA PRADESH
9848458225
drjyothirmai.ggh@gmail.com
Dr Perwez Khan
GSVM Medical College
Room No. 01, Ground Floor, Department of Opthalmology, Swaroop Nagar, Kanpur, - 208002, Uttar Pradesh, India. Kanpur Nagar UTTAR PRADESH
8400331200
drperwezkhan.research@gmail.com
Dr Ashok Kumar Nanda
KAR Vision Eye Hospital
3rd Floor, KAR Vision Eye Hospital, Plot no. 10, Janpath road, infront of Satya Nagar Bus Stop, Bhubaneswar, Odisha, 751007 Khordha ORISSA
9439001010
ashoknanda@hotmail.com
Dr Radkar Pranav Pramod
Lifepoint Multispecialty Hospital
Lifepoint Multispecialty Hospital, 3rd Floor, Clinical Research Department, 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune 411057, Maharashtra India Pune MAHARASHTRA
9527449733
radkarpranav@gmail.com
Dr Purvi Raj Bhagat
M&J Institute of Ophthalmology
113, Glaucoma Department, First Floor, Manjushri Mill compound, Asarwa, Ahmedabad 16, Gujarat, India Ahmadabad GUJARAT
9825985265
dr.purvibhagat@yahoo.com
Dr Bendale Pankaj Chudaman
National Institute of ophthalmology
OPD No. 6, 3rd Floor, Department of Ophthalmology, National Institute of ophthalmology, 1187/30, Off Ghole Road, Near Mahatma Phule Museum, Shivajinagar, Pune 411005, Maharashtra Pune MAHARASHTRA
7758903741
dr.pankajbendale@gmail.com
Dr Parth Jagdishkumar Rana
Netralaya Super Speciality Eye Hospital
Netralaya Super Speciality Eye Hospital
1st Floor, KD House, Above Union Bank of India, Opp. Gujarat Gas, Parimal Garden Cross Road, CG Road, Ahmedabad-380006, Gujarat, India.
Ahmadabad GUJARAT
Regional Institute of Ophthalmology, ground floor,
Room no.04. 88, College Street, Kolkata 700073
Kolkata WEST BENGAL
9836168771
drtaniaray@gmail.com
Dr Arjun Ahuja
Sandhu Kamal Eye Hospital
Sandhu Kamal Eye Hospital, Building No.2, R. NO.4,5,10 . Department of Ophthalmology, OPD Department Navjeevan Society, Mumbai- 400008 Mumbai MAHARASHTRA
9802118832
dr_arjunahuja@yahoo.com
Dr Kumar Niranjan
Sankat Mochan Nethralaya & Dental Care
B 36/4 -KH, Department of Ophthalmology, Saket Nagar Rd, Near Sankatmochan, Saket Nagar Colony, Lanka, Varanasi, Uttar Pradesh 221005 Varanasi UTTAR PRADESH
9415452360
sankatmochannetralaya@gmail.com
Dr Subhabrata Parida
SCB medical College and Hospital
Regional Institute of Ophthalmology, Department of Ophthalmology, ground floor, SCB medical College and Hospital, Cuttack, 573007 Cuttack ORISSA
9937041560
subhabrataparida@yahoo.com
Dr Joshi Deep Rageshbhai
Shivam Hospital
Shivam Hospital, C-4, Satyanarayan Society, Department of Ophthalmology, Ground Floor, Gor no Kuvo, Jashodanagar Cross Road, Maninagar East, Ahmedabad, Gujarat -380008, India. Ahmadabad GUJARAT
8238004065
admin@theshivamhospital.in
Dr Dharamveer Singh Choudhary
SMS Hospital
SMS Hospital,
Department Of Ophthalmology Charak Bhavan OPD Block J.L.N Marg SMS Hospital Jaipur-302004, Rajasthan
Jaipur RAJASTHAN
9252032662
drdschoudhary@gmail.com
Dr Mohita Sharma
Tirupati Eye Centre & Research Institute Pvt. Ltd
Tirupati Eye Centre & Research Institute Pvt. Ltd
C-53C, 6th Floor, Room No. 3, Sector-33 Near Noida Township Noida Uttar Pradesh-201301
Gautam Buddha Nagar UTTAR PRADESH
9560889495
drmohit@tirupatieye.org
Dr Arun Kumar Gupta
Uma Prem Netralay
UMA PREM NETRALAY, N6/13-E-1-2, Department of Ophthalmology, OPD Department, Indira Nagar Extension- 2, Chitaipur Varanasi, Uttar Pradesh – 221004 Varanasi UTTAR PRADESH
9454717085
drarunophtha@gmail.com
Dr Shilpa N
Vardhaman super specialty Eye Hospital
Vardhaman super specialty Eye Hospital, Department of Ophthalmology, Ground Floor, 60, 3rd Main Road, Next to Srirampura Metro station , Malleshwaram , Bangalore-5600021 Bangalore KARNATAKA
Institutional Ethics Committee Dr. D. Y. Patil Medial College, D.Y. Patil Hospital
Submittted/Under Review
Institutional Ethics Committee Medical College
Submittted/Under Review
Institutional Ethics Committee, SCB medical College and Hospital
Submittted/Under Review
Kar Vision Institutional Ethics Committee
Submittted/Under Review
Lifepoint Research Ethics Committee, Lifepoint Multispecialty Hospital
Submittted/Under Review
Opal Institutional Ethics Committee, Sankat Mochan Nethralaya & Dental Care
Submittted/Under Review
PBMA’s H.V, Desai Eye Hospital
Submittted/Under Review
Pranav Diabetes Center Ethics Committee, Vardhaman super specialty Eye Hospital
Submittted/Under Review
Sangini Hospital Ethics Committee
Approved
Shivam Ethics Committee, Shivam Hospital
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Brinzolamide and Timolol Ophthalmic Suspension
One drop of Brinzolamide and Timolol Ophthalmic Suspension (1% w/v + 0.5% w/v) should be instilled into conjunctival sac of the affected eye twice daily (preferably 12 hours apart) for 84 days.
Comparator Agent
NA
NA
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Patients of either gender aged ≥ 18 years who are willing to provide written informed consent
2. Patients diagnosed with Primary Open–angle glaucoma or Ocular hypertension
3. Patients who are on mono-therapy of either carbonic anhydrase inhibitors (CAIs) or Beta-blockers or any other IOP-lowering therapy and not adequately controlled
4. Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication
5. Male patients must have had a successful vasectomy or they and their female partners must meet the criteria above
ExclusionCriteria
Details
1. Patients with a history of allergic hypersensitivity to oral or topical Carbonic Anhydrase Inhibitors, Beta -blockers, sulfonamide drugs, or any components of these medications
2. Patients with acute or chronic conjunctivitis
3. Patients with reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
4. Patients with known/history of sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, and cardiogenic shock
5. Patients with uncontrolled hypertension, dry eye syndrome, diabetic retinopathy, hyperchloraemic acidosis and uncontrolled diabetes
6. Patients with severe allergic rhinitis
7. Patients using intraocular corticosteroid implant
8. Patients using contact lenses within 1 week prior to enrolment
9. Patients using the following medications within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid; 2) topical corticosteroid; 3) systemic corticosteroid, or 4) high dose salicylate therapy
10. Patients using intravitreal or subtenon injection of ophthalmic corticosteroid within 6 months prior to enrolment
11. Patients who are anticipated the need to initiate or modify medication that is known to affect IOP during the study period
12. Patients with severe renal impairment
13. Patients undergone intraocular surgery or laser surgery within the past 3 months
14. Patients currently using any systemic corticosteroid, or is having had therapy with any investigational agent within past 30 days
15. Patients with history of hematologic disorders other than mild anemia
16. Patients with history of non-compliance to medical regimens or those patients unwilling to comply with the study protocol
17. Patients with history of or currently having any of the severe/serious ocular condition or clinically significant medical conditions, such as cardiovascular, respiratory, renal, hepatic, endocrine, or gastrointestinal disease
18. Patients with history of or known case of HIV-AIDS, hepatitis B (Hep B), and hepatitis C (Hep C)
19. Participation in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to screening
20. Pregnant or lactating women and women of childbearing potential who are not using contraceptives
21. Investigator, study personnel, Sponsor representatives and their first degree relatives
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Proportion of patients with treatment-emergent adverse events (TEAEs)
Throughout the study period
Secondary Outcome
Outcome
TimePoints
Change from baseline in 2-hour post-dose IOP
Day 28, 56, and 84
Change from baseline in 0-hour pre-dose IOP
Day 28, 56, and 84
Target Sample Size
Total Sample Size="155" Sample Size from India="155" 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)
25/05/2023
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="10" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Not Applicable
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 4, single
arm, multicenter, open label study. The study will be conducted at
approximately 10-15 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 obtaining the informed consent, patients
will be screened by undergoing various assessments as mentioned in Schedule of
Assessment. After confirming the eligibility, test product Brinzolamide and
Timolol Ophthalmic Suspension (1% w/v + 0.5% w/v) will be instilled into the
affected eye twice daily. After 12 weeks of treatment period, the end of study visit
will be conducted. During the study, assessments will be performed as mentioned
in Schedule of Assessment.