| CTRI Number |
CTRI/2009/091/000578 [Registered on: 28/07/2009] |
| Last Modified On: |
22/02/2013 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A Multicenteric clinical study to compare Brinzolamide 1% Ophthalmic Suspension with Dorzox (Dorzolamide) 2% Ophthalmic Solution in treatment of Elevated Intra-Ocular Pressure in Patients with Primary Open Angle Glaucoma or Ocular Hypertension |
Scientific Title of Study
Modification(s)
|
A Multicenter, Open Label, Active Control, Parallel-Group Randomized Study to Demonstrate Non Inferiority of Brinzolamide 1% Ophthalmic Suspension compared With Dorzox (Dorzolamide) 2% Ophthalmic Solution in Treatment of Elevated Intra-Ocular Pressure in Patients with Primary Open Angle Glaucoma or Ocular Hypertension |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MA-CT-08-003 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Shalini Agarwal |
| Designation |
|
| Affiliation |
Manipal Acunova |
| Address |
Manipal Acunova Ltd., Mobius Towers, SJR-I-Park
EPIP, White Field.
Bangalore
KARNATAKA
560066
India |
| Phone |
91 80 - 66915776 |
| Fax |
+91 80 - 66915719 |
| Email |
shalini.agarwal@ecronacunova.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinod. M |
| Designation |
|
| Affiliation |
|
| Address |
Manipal Acunova Ltd., Mobius Towers, SJR-I-Park
EPIP, White Field
Bangalore
KARNATAKA
560066
India |
| Phone |
+91 80 - 66915754 |
| Fax |
+91 80 - 66915719 |
| Email |
vinod.m@ecronacunova.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Alcon laboratories (India) Pvt Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Alcon Laboratories India Pvt Ltd |
| Address |
Unit No. 502, 5th floor, Tower D, RMZ Infinity, Benniganahalli, Old Madras Road, Bangalore - 560016 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Krishnadas |
Aravind Eye Hospital |
1,Anna Nagar, ,-625020
|
0452 4356500
0452-2530984
krishnadas@aravind.org |
| Dr. R. Ramakrishnan |
Aravind Eye Hospital |
Swamy Nellaiappar High Road,-627 001
Tirunelveli
TAMIL NADU |
0462 ? 2337103
0462 ? 2331633
drrk@tvl.aravind.org |
| Dr. Sathyan |
Aravind Eye Hospital |
Avinashi Road,-641014
Coimbatore
TAMIL NADU |
0422 5542737
0422 259 3030
dr.sathyan.p@gmail.com |
| Dr. Venkatesh |
Aravind Eye Hospital |
Cuddalore Main Road,Thavalakuppam-605007
Pondicherry
PONDICHERRY |
0413 2618068
0422-259 3030
venkatesh@pondy.aravind.org |
| Dr. Rajesh Parekh |
Bhagwan Mahaveer Jain Hospital |
Millers Road,Vasanthnagar-560052
Bangalore
KARNATAKA |
080 -41426701
080-2226115
vision6by6@gmail.com |
| Dr. Rajashekar Dyaberi |
Karnataka Institute of Medical Sciences |
Madhavpur,-580020
|
0836 2261652
0836 2261652
dr.dyaberi@yahoo.co.in |
| Dr. Ramagopal B |
Narayana Nethralaya |
121 / c Chord Road,121 / c Chord Road-560010
Bangalore
KARNATAKA |
080 23373311
80-23377329
dr.ramgopal@gmail.com |
| Dr. Geetha Bengeri |
Siddarth Hospital |
Laxmi Campus,Laxmi Campus-580028
|
0836 2251178
0836 2261652
drgeetabengeri@yahoo.com |
| Dr. Reji Koshi |
St. Johns Medical College Hospital |
Sarjapur Road,-560034
Bangalore
KARNATAKA |
080 2206 5352
080 25635313
rejiann@gmail.com |
| Dr. Shobha Kini |
Vasan Eye Care Hospital |
F - 22, Raman Road,,A. V. K Nagar, Opp. New Bus Stand-636004
Salem
TAMIL NADU |
0427 4045502
0427 233 0401
slmkiniks@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Aravind Research Foundation Ethics Committee for Aravind Eye Hospital, Coimbatore |
Approved |
| Aravind Research Foundation Ethics Committee for Aravind Eye Hospital, Madurai |
Approved |
| Aravind Research Foundation Ethics Committee for Aravind Eye Hospital, Pondicherry |
Approved |
| Aravind Research Foundation Ethics Committee for Aravind Eye Hospital, Tirunelveli |
Approved |
| Bhagwan Mahaveer Jain Hospital Ethics Committee |
Approved |
| Hubli Clinical Research Center Ethics Committee for Karnataka Institute of Medical Sciences |
Approved |
| Hubli Clinical Research Center Ethics Committee for Siddarth Hospital |
Approved |
| Narayana Netralaya Ethics Committee |
Approved |
| St. Johns Medical College and Hospital, Institutional Ethics review Board |
Approved |
| Vasan Eye Care Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Primary Open Angle Glaucoma and Ocular Hypertension , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brinzolamide 1% ophthalmic suspension |
1 drop instilled in each eye, three times daily for 12 weeks |
| Comparator Agent |
Dorzox (dorzolamide) 2% ophthalmic solution |
1 drop instilled in each eye, three times daily for 12 weeks |
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Inclusion Criteria
Modification(s)
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.
2. IOP measurements ≥ 24 ≤ 36 mm Hg, in atleast one eye, at 9.00 am and ≥ 21 ≤ 36 mm Hg in atleast one eye (the same eye) at 11.00 am measurement
|
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| ExclusionCriteria |
| Details |
Patients with one sighted eye or amblyopia, history of chronic or recurrent inflammatory eye disease, ocular infections (3 months), ocular trauma, severe or progressive retinal or optic nerve disease, severe ocular pathology, intraocular surgery (last 12 months), laser surgery (last 3 months), current use of steroids or presence of any other form of glaucoma other than primary open angle glaucoma |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| IOP reduction from baseline |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IOP reduction from baseline |
4 and 8 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
11/02/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a multicenter, open label, active control, parallel-group randomized study to compare the reduction of elevated intra-ocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension. 200 patients with primary open angle glaucoma or ocular hypertension will be randomized to receive either the test or the comparator drug, instilled in the eye three times daily for a period of 12 weeks. The primary outcome measure is to demonstrate IOP reduction from baseline and demonstrate non inferiority of brinzolamide (test) 1% ophthalmic suspension compared with Dorzox (dorzolamide - comparator) 2% ophthalmic solution. |