WHO ICTRP trial

A multiple centre parallel group study comparing test drug Brinzolamide 1%…

CTRI/2015/01/005379 · Clinical Trials Registry India (CTRI) · Recruiting

Key facts

Trial ID CTRI/2015/01/005379
Public title A multiple centre parallel group study comparing test drug Brinzolamide 1% ophthalmic suspension to reference product of Brinzolamide (Azopt®) 1% ophthalmic suspension in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes
Scientific title A multicentre, double blind, active controlled, parallel group, two arm, bioequivalence study with clinical endpoint comparing Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon…
Primary sponsor Watson Pharma Pvt Ltd India
Registry Clinical Trials Registry India (CTRI)
Recruitment status Recruiting
Study type BA/BE
Countries India
Conditions Health Condition 1: null- Primary open angle glaucoma or ocular hypertension
Interventions Intervention1: Brinzolamide Ophthalmic suspension 1%, Manufactured by: Indoco Remedies, Ltd for Watson Pharma Pvt. Ltd: Each study subject will use 1 drop of test drug (Brinzolamide Ophthalmic Suspension 1%) in both the eyes 3 times daily…
Registration date Sep 1, 2015
Target size 950
Secondary IDs WAT/BNZL/2014, Version 3.0, 5 October 2015
Registry page ctri.nic.in

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