Clinical Trials

Brinzolamide has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4 to assess its safety and efficacy as both monotherapy and combination therapy for ocular conditions, including primary open-angle glaucoma, elevated intraocular pressure, and X-linked retinoschisis. Encompassing completed, withdrawn, and terminated studies, these global investigations are sponsored by diverse pharmaceutical companies and academic research institutions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02390284 TERMINATED
Glaucoma
University of Miami
 2015-09 PHASE3
NCT05022004 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension
Sun Pharmaceutical Industries Limited
 2021-12-20 PHASE3
NCT04944290 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Padagis LLC
 2021-05-28 PHASE3
NCT04523844 COMPLETED
Eye Diseases; Injection Complication; Intraocular Pressure
General Hospital of Athens Elpis
 2020-05-11
NCT04024072 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Padagis LLC
 2019-06-24 PHASE3
NCT03542006 UNKNOWN
Central Serous Chorioretinopathy
Tel-Aviv Sourasky Medical Center
 2018-06-01 PHASE2
NCT03896633 COMPLETED
Glaucoma; Open Angle or Ocular Hypertension
Bausch & Lomb Incorporated
 2018-02-28 PHASE1; PHASE2
NCT02730871 TERMINATED
Open-angle Glaucoma; Ocular Hypertension
Alcon Research
 2016-06-24 PHASE4
NCT03494257 COMPLETED
Cataract; Intraocular Pressure
University Hospital of Patras
 2017-09-04
NCT02419508 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2015-08-07 PHASE4
NCT03150160 COMPLETED
Glaucoma
Novartis Pharmaceuticals
 2017-09-21 PHASE4
NCT03192826 COMPLETED
Posterior Capsule Opacification; Ocular Hypertension
University Hospital of Patras
 2016-06-20 PHASE4
NCT02770248 COMPLETED
Glaucoma
Alcon Research
 2016-05-23 PHASE4
NCT02339584 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2015-04-14 PHASE3
NCT02512042 COMPLETED
Glaucoma
Actavis Inc.
 2015-04 PHASE3
NCT02325518 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon, a Novartis Company
 2014-12 PHASE4
NCT03966560 COMPLETED
Glaucoma, Open-Angle
Afyon Kocatepe University Hospital
 2014-01 PHASE4
NCT02140060 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2014-06 PHASE2
NCT01937312 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Alcon Research
 2013-10 PHASE4
NCT01937299 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Alcon Research
 2013-10 PHASE4
NCT01978600 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2013-10 PHASE4
NCT01312402 COMPLETED
Infantile Nystagmus Syndrome
Akron Children's Hospital
 2011-01 PHASE4
NCT01415401 COMPLETED
Glaucoma; Ocular Hypertension; Open-angle Glaucoma
Alcon Research
 2011-09 PHASE4
NCT01263444 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2011-03 PHASE4
NCT01721707 WITHDRAWN
Open Angle Glaucoma; Ocular Hypertension
Adapt Produtos Oftalmológicos Ltda.
 2012-12 PHASE3
NCT00869141 COMPLETED
Glaucoma
University of California, Los Angeles
 2009-03 PHASE4
NCT01518244 COMPLETED
Glaucoma
Alcon Research
 2011-12 PHASE4
NCT01309204 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-05 PHASE3
NCT01357616 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2010-11 PHASE3
NCT01310777 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-05 PHASE3
NCT01340014 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-09 PHASE4
NCT01722604 COMPLETED
Glaucoma; Open Angle or Ocular Hypertension
Bausch & Lomb Incorporated
 2012-01 PHASE3
NCT01514734 TERMINATED
Glaucoma
Alcon Research
 2012-03 PHASE4
NCT01297920 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-03 PHASE3
NCT01297517 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-02 PHASE3
NCT01484951 COMPLETED
Glaucoma
Alcon Research
 2011-05 PHASE4
NCT00800540 COMPLETED
Glaucoma
Alcon Research
 2009-02 PHASE4
NCT01426867 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-09 PHASE2
NCT01111890 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2010-04 PHASE4
NCT01471158 COMPLETED
Glaucoma
Alcon Research
 2010-09 PHASE4
NCT01084902 UNKNOWN
Ocular Hypertension
Peking University First Hospital
 2010-02
NCT00981786 COMPLETED
Glaucoma
Aristotle University Of Thessaloniki
 2009-08 PHASE4
NCT00966576 COMPLETED
Glaucoma
Alcon Research
 2009-07 PHASE4
NCT00761995 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2009-02 PHASE4
NCT00961649 TERMINATED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2009-10 PHASE2
NCT00759941 COMPLETED
Glaucoma
Alcon Research
 2007-10 PHASE4
NCT00767494 TERMINATED
Glaucoma; Ocular Hypertension
Alcon Research
 2008-10 PHASE3
NCT00767481 TERMINATED
Glaucoma; Ocular Hypertension
Alcon Research
 2008-10 PHASE3
NCT00471380 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2007-03 PHASE4
NCT00758342 TERMINATED
Intraocular Pressure
Alcon Research
 2006-05 PHASE4
NCT00527501 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Alcon Research
 2007-08 PHASE2
NCT00300079 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension
Alcon Research
 2006-09 PHASE4
NCT00382226 COMPLETED
Glaucoma
Alcon Research
 2006-09 PHASE4
NCT00314171 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Alcon Research
 2005-10 PHASE3
NCT00675207 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension
Northwestern Ophthalmic Institute S.C.
 2006-01 PHASE4
NCT00440141 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2006-07 PHASE4
NCT00314158 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Alcon Research
 2005-11 PHASE3
NCT00326092 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Alcon Research
 2006-05 PHASE2
NCT00061516 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2003-01 PHASE3
NCT00372827 COMPLETED
Primary Open-angle Glaucoma; Ocular Hypertension; Pigment Dispersion Glaucoma
Alcon Research
 2004-02 PHASE4
NCT00121147 COMPLETED
Open Angle Glaucoma; Ocular Hypertension; Pseudoexfoliation Syndrome
Hermann Eye Center
 2003-09

(data from https://clinicaltrials.gov, updated on 2025-08-26)

Check the Brinzolamide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brinzolamide potently inhibits carbonic anhydrase II with an IC50 of 3.19 nM, blocking the conversion of carbon dioxide to bicarbonate within the ciliary body processes of the eye. This reduction in bicarbonate formation decreases active aqueous humor secretion, thereby effectively lowering intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.