PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Sat, 16 Mar :17:51 GMT) CTRI Number Last Modified On 03/10/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/03/ [Registered on: 15/03/2012] - Trial Registered Prospectively No BA/BE Randomized, Parallel Group Trial STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE OF GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION MANUFACTURED BY INNOPHARMA INC 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 AZOPT (BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION) IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CD NIL Designation Affiliation Phone Fax Designation Affiliation Phone Fax Designation Affiliation Protocol Number NIL Details of Principal Investigator Dr Leslie Ravi Principal Investigator Diabetic Centre Diabetic Centre #426,4th Cross,2nd Block,Kalyan Nagar, leslieravikumar@yahoo.co.in Details Contact Person (Scientific Query) Dr Leslie Ravi Principal Investigator Diabetic Centre Diabetic Centre #426,4th Cross,2nd Block,Kalyan Nagar, leslieravikumar@yahoo.co.in Details Contact Person (Public Query) Dr Leslie Ravi Principal Investigator Diabetic Centre Diabetic Centre #426,4th Cross,2nd Block,Kalyan Nagar, page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > InnoPharma Inc Type of Sponsor Semler Research Center Pvt Ltd List of Countries Malaysia Singapore Sri Lanka United States of America of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details InnoPharma Inc InnoPharma, Inc.10 Knightsbridge Rd. Suite III Piscataway, NJ Pharmaceutical industry-global 75A, 15th Cross, I Phase J.P.Nagar, , INDIA of Site Site Phone/Fax/ Dr Kummararaj G AG Eye care Hospitals AG Eye care Hospitals # 6, Officers Colony Puttur Opp To G H, Puthur, Trichy Tiruchirappalli TAMIL NADU Dr Lelie Ravikumar Diabetic Centre gkageye@gmail.com Diabetic Centre #426,4th Cross,2nd Block,Kalyan leslieravikumar@yahoo. Nagar, co.in 3 Dr Srihargava Natesh Nethra Eye Hospital Nethra Eye Hospital #8,Poojary Layout,80 Ft Road,RMV 2nd stage, sribhargava.natesh@g mail.com Dr Deval Shah NETR eye care clinic NETR eye care clinic #Vision House Opposite Kameshwar School,Near Jodhpur Cross road,satellite,ah medabad ,gujar at Ahmadabad GUJARAT gunvant.atre@i5clinicalr esearch.com page 2 / 8

3 Details of Ethics Committee 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 Mumbai MAHARASHTRA Dr Sowbhagya Shankara Netralaya #41-42/45 Sri Krupa 7th cross,saraswatipur am,nandini Layout Main Road, nita@eyesurgeon.in hnbhagya@yahoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Ethics Committee/Bang alore/dr. Leslie Ravi, No 1423, Kullappa Layout, Kullappa Circle, ST. Thomas Town P.O., , Karnataka, Approved 20/02/2012 Yes IEC Consultants/Bangal Not Applicable No Date Specified Yes ore/dr. Kummararaj, "Darussalam", 598,2ndCross,17th Main, 3rd Block,Korama ngala, , IEC Consultants/Bangal Not Applicable No Date Specified Yes ore/dr. Sowbhagya HN, "Darussalam", 598,2ndCross,17th Main, 3rd Block,Korama ngala, , IEC Consultants/Bangal Not Applicable No Date Specified Yes ore/dr. Sribhargava Natesh, "Darussalam", 598,2ndCross,17th Main, 3rd Block,Korama ngala, , MANAV Independent Ethics Committee/Dr. Deval Shah/ Ahmedabad, Shree Raj Hospital, 1st Floor, Maruti Centre, Gurukul Road, Memnagar, Ahmedabad , The KELKAR Education Trusts, Independent Scientific and Ethics Co Not Applicable No Date Specified Yes Approved 13/02/2012 Yes page 3 / 8

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria mmittee/mumbai/dr.nit a Shanbhag, Trust Office, 3rd floor, V.G.Vaze College campus, Mithagar Road, Mulund(E), Mumbai Status Not Applicable Health Type Patients Date No Date Specified Condition PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION Type Details Intervention GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION Comparator Agent AZOPT (BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION) Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 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. 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.) 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. page 4 / 8

5 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 Exclusion Criteria Details Exclusion Criteria 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 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 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 Method of Generating Random Sequence Computer generated randomization page 5 / 8

6 Method of Concealment Blinding/Masking Other 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 Azopt (Brinzolamide 1% ophthalmic suspension). 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 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 Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=286 Sample Size from =72 07/05/ /02/2012 Years=2 Months=0 Days=0 Completed Other (Terminated) The publication policy will be at the discretion of the Sponsor. If published the patients identity will not be revealed. 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 Azopt (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,, Singapore, Malaysia and Srilanka page 6 / 8

7 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 page 7 / 8

8 Powered by TCPDF ( page 8 / 8