| CTRI Number |
CTRI/2012/03/002494 [Registered on: 15/03/2012] Trial Registered Prospectively |
| Last Modified On: |
03/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE OF GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION MANUFACTURED BY INNOPHARMA INC |
|
Scientific Title of Study
|
A MULTICENTER, DOUBLE-MASKED, RANDOMIZED, PARALLEL ASSIGNMENT, STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE OF GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION MANUFACTURED BY INNOPHARMA INC. WITH RESPECT TO AZOPTâ„¢ (BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION) IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CD-11-265 |
Protocol Number |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Leslie Ravi |
| Designation |
Principal Investigator |
| Affiliation |
Bangalore Diabetic Centre |
| Address |
Bangalore Diabetic Centre #426,4th Cross,2nd Block,Kalyan Nagar,Bangalore-560043
Bangalore
KARNATAKA
560043
India |
| Phone |
|
| Fax |
|
| Email |
leslieravikumar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leslie Ravi |
| Designation |
Principal Investigator |
| Affiliation |
Bangalore Diabetic Centre |
| Address |
Bangalore Diabetic Centre #426,4th Cross,2nd Block,Kalyan Nagar,Bangalore-560043
Bangalore
KARNATAKA
560043
India |
| Phone |
|
| Fax |
|
| Email |
leslieravikumar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leslie Ravi |
| Designation |
Principal Investigator |
| Affiliation |
Bangalore Diabetic Centre |
| Address |
Bangalore Diabetic Centre #426,4th Cross,2nd Block,Kalyan Nagar,Bangalore-560043
Bangalore
KARNATAKA
560043
India |
| Phone |
|
| Fax |
|
| Email |
leslieravikumar@yahoo.co.in |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
InnoPharma Inc |
| Address |
InnoPharma, Inc.10 Knightsbridge Rd.
Suite III Piscataway, NJ 08854
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Semler Research Center Pvt Ltd |
75A, 15th Cross, I Phase J.P.Nagar, Bangalore 560 078, INDIA |
|
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Countries of Recruitment
|
Singapore
India
Malaysia
Sri Lanka
United States of America |
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Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kummararaj G |
AG Eye care Hospitals |
AG Eye care Hospitals # 6, Officers Colony Puttur Opp To G H, Puthur, Trichy - 620017
Tiruchirappalli
TAMIL NADU |
09894545554
04314542325
gkageye@gmail.com |
| Dr Lelie Ravikumar |
Bangalore Diabetic Centre |
Bangalore Diabetic Centre #426,4th Cross,2nd Block,Kalyan Nagar,Bangalore-560043
Bangalore
KARNATAKA |
9980011225
leslieravikumar@yahoo.co.in |
| Dr Srihargava Natesh |
Nethra Eye Hospital |
Nethra Eye Hospital #8,Poojary Layout,80 Ft Road,RMV 2nd stage, Bangalore-560094
Bangalore
KARNATAKA |
9342880273
sribhargava.natesh@gmail.com |
| Dr Deval Shah |
NETR eye care clinic |
NETR eye care clinic #Vision House Opposite Kameshwar School,Near Jodhpur Cross road,Satellite,Ahmedabad-380015,Gujarat
Ahmadabad
GUJARAT |
08690543200
gunvant.atre@i5clinicalresearch.com |
| Dr Nita Shanbhag |
Omkar Eye Care Centre |
Omkar Eye Care Centre #302,303 Koteshwar Plaza junction of RHB Rd & J Nehru Rd,Mulund West Mumbai-400080
Mumbai
MAHARASHTRA |
09322402424
nita@eyesurgeon.in |
| Dr Sowbhagya |
Shankara Netralaya |
#41-42/45 Sri Krupa 7th cross,Saraswatipuram,Nandini Layout Main Road,Bangalore-96
Bangalore
KARNATAKA |
09620937759
hnbhagya@yahoo.co.in |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee/Bangalore/Dr. Leslie Ravi, No 1423, Kullappa Layout, Kullappa Circle, ST. Thomas Town P.O., Bangalore 560084, Karnataka, India |
Approved |
| IEC Consultants/Bangalore/Dr. Kummararaj , "Darussalam", 598,2ndCross,17th Main, 3rd Block,Koramangala,Bangalore-560034, India |
Not Applicable |
| IEC Consultants/Bangalore/Dr. Sowbhagya HN, "Darussalam", 598,2ndCross,17th Main, 3rd Block,Koramangala,Bangalore-560034, India |
Not Applicable |
| IEC Consultants/Bangalore/Dr. Sribhargava Natesh, "Darussalam", 598,2ndCross,17th Main, 3rd Block,Koramangala,Bangalore-560034, India |
Not Applicable |
| MANAV Independent Ethics Committee/Dr. Deval Shah/ Ahmedabad, Shree Raj Hospital, 1st Floor, Maruti Centre, Gurukul Road, Memnagar, Ahmedabad-380052, India |
Not Applicable |
| The KELKAR Education Trusts, Independent Scientific and Ethics Committee/Mumbai/Dr.Nita Shanbhag, Trust Office, 3rd floor, V.G.Vaze College campus, Mithagar Road, Mulund(E), Mumbai-400 081 |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AZOPTâ„¢ (BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION) |
Brinzolamide belongs to a new class of heterocyclic sulfonamide CAIs that is topically active for reducing IOP. It has high affinity and inhibitory potency against human CA II, an isoenzyme of carbonic anhydrase found in the ciliary epithelia, which are involved with aqueous humor secretion. Brinzolamide is formulated as an aqueous suspension and at physiologic pH. The optimum concentration of brinzolamide for lowering elevated IOP is 1.0%, based on dose-response studies over the concentration range of 0.3% to 3.0%, when administered twice daily (b.i.d.) |
| Intervention |
GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION |
Brinzolamide belongs to a new class of heterocyclic sulfonamide CAIs that is topically active for reducing IOP. It has high affinity and inhibitory potency against human CA II, an isoenzyme of carbonic anhydrase found in the ciliary epithelia, which are involved with aqueous humor secretion
Dosage: One drop topically instilled into each eye three times a day for the period of 12 weeks. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension (including pigment dispersion syndrome).
2. If of child bearing potential -
• Must use a reliable means of contraception for the duration of the study or surgically sterilized.
• Must have a negative pregnancy test.
• Must be non-lactating
3. 9 am IOP measurements ≥ 24 ≤ 36 mmHg, inclusive, in at least one eye, at two eligibility visits separated by one week
4. The IOP criteria to be met by the same eye
5. Visual Acuity of 6/24 or better(or its equivalent by logMAR) in both eyes
6. Gonioscopy angle of ≥ 3 in both eyes
7. Patients with a level of understanding and willingness to fully comply with all visits and study procedures scheduled by the study site as evidenced by written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with any form of glaucoma other than open-angle glaucoma
2. Patients with Schaffer angle grade 3 (overall, however occludable angles treated with patent iridectomy are allowed )
3. Patients with a cup/disc ratio greater than 0.8
4. Patients with severe central visual field loss
5. Best corrected VA score worse than 20/200 Snellen (equivalent to +1.0 log Mar)
6. Chronic, recurrent or severe inflammatory eye disease (blepharitis or clinically non-significant conjunctival hyperaemia allowed)
7. Clinically significant or progressive retinal disease or optic nerve disease from any cause apart from glaucoma
8. Other ocular pathology especially Fuch’s endothelial dystrophy, moderate to severe guttata, subjectively low endothelial cell count by slit lamp biomicrscopy or any abnormality preventing reliable applanation tonometry
9. Recent, current, or anticipated treatment with any medication that augments adrenergic
responses, or precludes use of an alpha-adrenergic agonist like MAO inhibitors.
10. History of hypersensitivity to oral or topical CAIs, sulfonamide drugs or to any
component of these medications or the study medications or ingredients
11. Contact lens use during the active treatment portion of the trial. However if patient agrees to avoid use of contact lens use 15 minutes before and after drug administration, such patient can be included
12. Active ocular allergies.
13. Conventional ocular surgery or laser surgery within the 3 months prior to visit 1.
14. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
15. Active ocular diseases or uncontrolled systemic disease. Patients requiring concomitant aggressive therapy with antihypertensives or steroids or patients on oral CAIs like acetazolamide or methazolamide. However patients on stable dose of antihypertensive therapy or stable doses of dermal or inhaled steroids can be allowed
16. Pregnant or nursing mothers and females of childbearing potential not practicing a
reliable and medically acceptable method of birth control
17. Participation in any study during past 30 days
18. Relative or employee of the treating investigator
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azoptâ„¢ (Brinzolamide 1% ophthalmic suspension). |
To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azoptâ„¢ (Brinzolamide 1% ophthalmic suspension). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and efficacy of Brinzolamide 1% ophthalmic suspension in patients with primary open angle glaucoma or ocular hypertension |
NA |
|
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Target Sample Size
|
Total Sample Size="286"
Sample Size from India="72"
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)
|
07/05/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2012 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
The publication policy will be at the discretion of the Sponsor. If published the patients identity will not be revealed. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
A multicenter, double-masked, randomized, parallel assignment, study to determine the therapeutic equivalence of generic Brinzolamide 1% ophthalmic suspension manufactured by InnoPharma Inc with respect to Azoptâ„¢ (Brinzolamide 1% ophthalmic suspension) in patients with primary open angle glaucoma or ocular hypertension
Phase III therapeutic equivalence trial
Male and female patients 18 years of age or older, diagnosed with open-angle glaucoma or ocular hypertension.
286 evaluable patients with primary open angle glaucoma or ocular hypertension with provision for approximate drop-out rate of 20 %.
Multiple centers each across US, India, Singapore, Malaysia and Srilanka are planned
Primary objective :
· To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azopt™ (Brinzolamide 1% ophthalmic suspension).
Secondary objective:
To evaluate the safety and efficacy of Brinzolamide 1% ophthalmic suspension in patients with primary open angle glaucoma or ocular hypertension
Primary Outcome Measures:
· Intraocular pressure (IOP) at baseline and at 4, 8 and 12 weeks after treatment.
Secondary Outcome Measures:
- Reduction in intraocular pressure (IOP) from baseline at the end of 4, 8 and 12 weeks of treatment.
- Occurrence of adverse events during the study
|