| CTRI Number |
CTRI/2015/07/006043 [Registered on: 22/07/2015] 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 1.0% w/v plus Brimonidine Tartrate 0.2 % w/v Ophthalmic Suspension compared with Brinzolamide 1% eye drops for the Treatment of patients with Open-Angle Glaucoma or Ocular Hypertension. |
|
Scientific Title of Study
|
A Clinical Study to evaluate the Efficacy , Safety and Tolerability of Brinzolamide 1.0% w/v plus Brimonidine Tartrate 0.2 % w/v Ophthalmic Suspension Vs. Brinzolamide 1% eye drops in patients with Open-Angle Glaucoma or Ocular Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/12/004;Version No.:1 dated 24.11.2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Parekh |
| Designation |
Consultant Ophthalmologist |
| Affiliation |
Bhagwan Mahavir Jain Hopsital |
| Address |
Bhagwan Mahavir Jain Hopsital, Millers Road, Vasanthnagar,
Bangalore – 560052
Bangalore
KARNATAKA
560052
India |
| Phone |
9945544744 |
| Fax |
080-22261153 |
| Email |
eyetrials@gmail.com |
|
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
400 067
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 |
|
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-6062111 |
| Fax |
022-6061200 |
| Email |
shailesh.singh@ajantapharma.com |
|
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Source of Monetary or Material Support
|
|
|
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 |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 21 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mary Abraham |
Apollo first med Hospital |
Apollo first med Hospital, 154, P. K. Road, Kilpauk, Chennai - 600010.
Chennai
TAMIL NADU |
9841700824
beulah.f@aherf-smo.org |
| Dr Gayatri Devendra Hoshing |
Aster Aadhar Hospital (Prerana Hospital Ltd.) |
R.S. No. 628, B Ward, Near Shastri nagar, KMT workshop, Kolhapur 416012. Maharashtra
Kolhapur
MAHARASHTRA |
9422493335
mantrolikar@yahoo.com |
| Dr Rajesh Parekh |
Bhagwan Mahaveer Jain Hospital |
Department Of Opthalmolgy,
Room no. 11, Millers Road, Vasanthnagar,
Bangalore – 560052.
Bangalore
KARNATAKA |
09945544744
eyetrials@gmail.com |
| Dr Nandini Momaya |
Bhatia Hospital Medical Research Society |
Bhatia Hospital Medical Research Society, Bhatia Hospital Tardeo Road, Grant Road (W), Mumbai-400007. Maharashtra.
Mumbai
MAHARASHTRA |
02222024809
crc.bhmrs@gmail.com |
| Dr Gurkirat Singh Bajwa |
Dayanand Medical College & Hospital |
Department of Ophthalmology,
1st Floor, Room No.1
Tagore Nagar, Civil Lines,
Ludhiana – 141001, Punjab.
Ludhiana
PUNJAB |
09814031105
gbajwa9@rediffmail.com |
| Dr Nita U Shanbhag |
Dr. D. Y. Patil Medical Hospital |
Dr. D. Y. Patil Medical Hospital, Sector-5, Nerul (E), Navi Mumbai - 400614.
Mumbai (Suburban)
MAHARASHTRA |
9322402424
nita@eyesurgeon.in |
| Dr Mohua Mazumdar |
Institute of Post Graduate Medical Education & Research |
Institute of Post Graduate Medical Education & Research, 244,
A.J.C. Bose Road,
Kolkata-700020. West Bengal.
Kolkata
WEST BENGAL |
09830682007
mazumder_mahua@yahoo.com |
| Dr Prasenjit Maiti |
IPGMER & SSKM Hospital |
244, A.J.C Bose Road, Kolkata, 70020. West Bengal
Kolkata
WEST BENGAL |
9831044795
sreejitamaiti@gmail.com |
| Dr Vijaya Pai H |
Kasturaba Medical College and Hospital |
Kasturaba Medical College and Hospital, Madhav Nagar, Manipal -576104.
Karnataka.
Mysore
KARNATAKA |
9845426427
paivijaya@yahoo.co.in |
| Dr Pramod Kumar |
King George Medical college |
Department of Opthalmology(South wing)King Georges medical college chowk, Lucknow-226003
Lucknow
UTTAR PRADESH |
9838894091
Pramodkumar2020@rediffmail.com |
| Dr Vyavahare Deepali Dattatraya |
Lifepoint Multispecialtiy Hospital |
Lifepoint Multispecialtiy Hospital, 145/1, Mumbai Banglore Higway Near Hotel Sayaji, Wakad,
Pune-411057.
Maharashtra.
Pune
MAHARASHTRA |
9730475068
lp.feasibility@gmail.com |
| Dr Purvi Raj Bhagat |
M & J Western Regional Institute of Ophthalmology And Civil Hospital |
M & J Western Regional Institute of Ophthalmology And Civil Hospital, Asarwa, Ahmedabad - 380016.
Gujarat.
Ahmadabad
GUJARAT |
7922680360
dr.purvibhagat@yahoo.com |
| Dr Chittranjan Shaw |
Medical College Hospital |
Regional Institute of Ophthalmology, Medical College Hospital, 88, College Street, Kolkata- 700033.
Kolkata
WEST BENGAL |
9477371192
pralay.87@rediffmail.com |
| Dr Gupta Prabodhini Ajay |
Medipoint Hospital Pvt. Ltd |
Medipoint Hospital Pvt. Ltd.,
241/1, New D.P. Road, Aundh, Pune-411007.
Maharashtra.
Pune
MAHARASHTRA |
9822495795
prabodh1@hotmail.com |
| 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 Kumudini Sharma |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Ophthalmology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, lucknow - 226014.
Uttar Pradesh.
Lucknow
UTTAR PRADESH |
7408890080
drpradhyumman@gmail.com |
| Dr Arjun Ahuja |
Seth GS Medical College & KEM Hospital |
Department of Ophthalmology, Seth GS Medical College & KEM Hospital, Parel,
Mumbai-400012.
Maharashtra.
Mumbai
MAHARASHTRA |
9820118832
dr_arjunahuja@yahoo.com |
| Dr Anupama Vyas |
Shalby Hospitals |
Shalby Hospitals, Opp. Karnavati Club, S. G. Highway,
Ahmedabad-380015.
Gujarat.
Ahmadabad
GUJARAT |
7698442447
byasanupama@yahoo.co.in |
| Dr Nilesh Viinaychandra Parekh |
Sir T Hospital & Govt. Medical College |
Department of Ophthalmology, Sir T Hospital & Govt. Medical College, Bhavnagar-364001. Gujarat.
Bhavnagar
GUJARAT |
9825252673
drnvparekh@hotmail.com |
| Dr Radha Annamalai |
Sri Ramchandra Hospital |
Sri Ramchandra Hospital, No.: 1, Ramachandra Nagar, Porur,
Chennai - 600116.
Tamilnadu.
Chennai
TAMIL NADU |
9500193396
drradhaannamalai@yahoo.co.in |
| Dr T Ajay Chakravarthy |
St. Theressa Hospital |
St. Theresa’s Hospital,
Sanathnagar,
Hyderabad-500018.
Telangana.
Hyderabad
ANDHRA PRADESH |
9908114725
ajaychakravarthy@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Aster Aadhar Ethics Committee |
Approved |
| B.J. Medical College & Civil Hospital |
Approved |
| Clinical Trial Ethics Committee_Bhatia Hospital |
Approved |
| Dayanand Medical College & Hospital |
Approved |
| Ethics Committee, Apollo Hospital |
Approved |
| Ethics Committee_Kasturba Medical College |
Approved |
| Ethics Committee_St Theresa Hospital |
Approved |
| Institute Ethics Committee, SGPGI Bioethics Cell |
Submittted/Under Review |
| Institutional Ethics Committee Bhagwan Mahaveer Jain Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Regional Institute of Ophthalmology |
Approved |
| Institutional Ethics Committee, Shalby Hospital |
Submittted/Under Review |
| Institutional Ethics Committee,KEM Hospital |
Approved |
| Institutional Ethics Committee,Kings George’s Medical University |
Approved |
| Institutional Ethics Committee_Sri Ramachandra University |
Approved |
| IPGME&R Research Oversight Committee at Office of the Dean |
Approved |
| LPR ethics Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
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 |
| Comparator Agent |
Brinzolamide 1% eye drop |
1-2 drops twice daily in affected eye(s) for 12 weeks. |
| Intervention |
Brinzolamide 1.0% w/v plus Brimonidine Tartrate 0.2 % w/v Ophthalmic Suspension |
1-2 drops twice daily in affected eye(s) for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•A clinical diagnosis of glaucoma or Ocular hypertension at least in at one (study) eye.
•IOP between 21 to less tnan and equal 36 mm of Hg.
•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, Miotics (7 days), Alpha Agonist and Alpha/beta agonist (14 days), β antagonist and prostaglandin analogs (21 days).
Subject with H/O discontinued Carbonic anhydrase inhibitor since past 4 months.
•Voluntary willingness to give written informed consent prior to participation in trial.
|
|
| ExclusionCriteria |
| Details |
Any history of:
•Ocular trauma or intraocular surgery within the past 6 months;
•Ocular infection, inflammation, or laser surgery within the past 3 months;
Any present observation of:
•Chronic, recurrent or severe inflammatory eye disease.
•Central cornea thickness 620 mm, as measured by pachymetry, in either eye.
•Shaffer angle grade less than 2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, more than 20]), as measured by Gonioscopy.
•Severe central visual field loss in either eye measured by Perimetry.
•Clinically significant or progressive retinal disease.
•Best-corrected visual acuity worse than 0.6 logMAR (Best Corrected VA score worse than 55 ETDRS letters (20/80 Snellen equivalent).
•Other ocular pathology (including severe dry eye) that may preclude the administration of an alpha-adrenergic agonist and/or a topical CAI.
•Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
•Patients who are required to wear contact lens during the study period.
•Cup/disc ratio greater than 0.80.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| •The primary end point for assessing efficacy will be the reduction in IOP (Intraocular Pressure) measured by Tonometry |
1st week, 2nd week, 4th week, 8th week, 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Percentage of patients reaching the defined IOP (intraocular pressure) 20 mmHg for general population, and ≤20 mmHg for elderly) |
12th week |
| •Percentage of patients reporting AE and/or SAE during the study. |
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)
|
10/08/2015 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 multicentric, double blind, randomized, active control, parallel group comparative Study to evaluate the Efficacy, Safety and Tolerability of Brinzolamide 1.0% w/v plus Brimonidine Tartrate 0.2% w/v Ophthalmic Suspension Vs. Brinzolamide 1% eye drops in 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 1st 2nd, 4th, 8th and 12th week of treatment for clinical assessment: The mean reduction in IOP of the treatment groups will be assessed using descriptive statistics. The improvement in IOP from baseline to the end of treatment period will be compared by Chi square test. The secondary outcome will be measured as Percentage of patients reaching the defined IOP (intraocular pressure) <20 mmHg for general population, and ≤20 mmHg for elderly) at the final visit of the study and Percentage of patients reporting AE and/or SAE during the study. |