Clinical Trials

Dorzolamide hydrochloride is the subject of numerous clinical trials investigating ophthalmic conditions including open-angle glaucoma, ocular hypertension, elevated intraocular pressure, and X-linked retinoschisis. Sponsored by commercial entities and academic institutions, these active, completed, and terminated protocols span Phase 1 through Phase 4 evaluations aimed at optimizing topical intraocular pressure reduction.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07690397 ACTIVE_NOT_RECRUITING
Primary Open-Angle Glaucoma (POAG); Ocular Hypertension
Tecnoquimicas
 2026-06-10 PHASE4
NCT05857267 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Laboratorios Poen
 2023-03-07 PHASE4
NCT03193333 TERMINATED
Primary Open-angle Glaucoma
Laboratorios Sophia S.A de C.V.
 2017-11-06 PHASE3
NCT02390284 TERMINATED
Glaucoma
University of Miami
 2015-09 PHASE3
NCT06369077 TERMINATED
Glaucoma, Open-Angle; Glaucoma; Drugs
CT Glaucoma Associates
 2024-04-22 PHASE4
NCT04702789 TERMINATED
Glaucoma, Open-Angle; Ocular Hypertension
Laboratorios Sophia S.A de C.V.
 2021-10-19 PHASE4
NCT04676126 WITHDRAWN
Glaucoma; Glaucoma Eye; Glaucoma, Open-Angle
University of the Incarnate Word
 2021-05 PHASE4
NCT05083689 UNKNOWN
Diabetic Macular Edema
Shahid Beheshti University of Medical Sciences
 2021-10-06 PHASE2; PHASE3
NCT02852057 COMPLETED
Glaucoma
University of Florida
 2018-01-18 PHASE1
NCT03034772 COMPLETED
Neovascular Age-related Macular Degeneration; Wet Macular Degeneration
Wills Eye
 2017-02-08 PHASE2; PHASE3
NCT02967614 COMPLETED
Glaucoma; Eye Diseases; Ocular Hypertension
Kukje Pharma
 2016-12 PHASE1
NCT02967614 Completed
Glaucoma|Eye Diseases|Ocular Hypertension
Kukje Pharma
 2016-12 Phase 1
NCT01527682 COMPLETED
Childhood Glaucoma
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
 2009-07 PHASE2
NCT02053298 COMPLETED
Open Angle Glaucoma
Universitaire Ziekenhuizen KU Leuven
 2014-01 PHASE4
NCT02325518 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon, a Novartis Company
 2014-12 PHASE4
NCT02802137 COMPLETED
Glaucoma; Ocular Surface Disease
Aristotle University Of Thessaloniki
 2015-03 PHASE4
NCT02571972 COMPLETED
Wet Macular Degeneration; Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion
Wills Eye
 2015-02-01 PHASE2
NCT00716586 COMPLETED
Retinal Degenerations
University of Illinois at Chicago
 2005-10 PHASE4
NCT03966560 COMPLETED
Glaucoma, Open-Angle
Afyon Kocatepe University Hospital
 2014-01 PHASE4
NCT00275756 WITHDRAWN
Glaucoma
Medical University of Vienna
 2008-09
NCT02522039 COMPLETED
Drug Effect (Glaucoma Drugs)
Glostrup University Hospital, Copenhagen
 2014-05
NCT01175902 COMPLETED
Normal Tension Glaucoma
The Catholic University of Korea
 2011-03
NCT01284166 WITHDRAWN
Glaucoma; Ocular Hypertension
Allergan
 2013-07 PHASE3
NCT01228149 COMPLETED
Glaucoma
Katrin Lorenz
 2010-08 PHASE4
NCT01896180 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension; Elevated Intraocular Pressure
Alleanza Pharmaceuticals, Inc.
 2013-07 PHASE2
NCT01257698 COMPLETED
Macular Hole; Retinal Detachment
Mid Atlantic Retina
 2010-02
NCT01843920 COMPLETED
Scleral Buckling
Jason Hsu, MD
 2011-06
NCT00869141 COMPLETED
Glaucoma
University of California, Los Angeles
 2009-03 PHASE4
NCT01340014 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-09 PHASE4
NCT00824824 COMPLETED
Glaucoma
Massachusetts Eye and Ear Infirmary
 2009-01
NCT00906087 COMPLETED
Glaucoma
University of Michigan
 2009-08-04 PHASE4
NCT00815373 WITHDRAWN
Open-Angle Glaucoma; Ocular Hypertension
Meir Medical Center
 2008-12
NCT00957190 COMPLETED
Eye Disease
Maisonneuve-Rosemont Hospital
 2009-05-04 PHASE4
NCT01111890 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2010-04 PHASE4
NCT01471158 COMPLETED
Glaucoma
Alcon Research
 2010-09 PHASE4
NCT00619034 COMPLETED
Diabetic Retinopathy
University of Aarhus
 2007-09
NCT00761995 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2009-02 PHASE4
NCT00832377 COMPLETED
Glaucoma
Merck Sharp & Dohme LLC
 2009-04-24 PHASE2
NCT00878917 COMPLETED
Open Angle Glaucoma; Ocular Hypertension
Alfred E. Tiefenbacher (GmbH & Co. KG)
 2009-04 PHASE3
NCT00811850 COMPLETED
Glaucoma
Allergan
 2008-12 PHASE4
NCT00572936 COMPLETED
Glaucoma
University of Nebraska
 2006-03-13 PHASE2
NCT00972257 COMPLETED
Glaucoma
Aristotle University Of Thessaloniki
 2009-01 PHASE4
NCT00471380 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2007-03 PHASE4
NCT00545064 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Merck Sharp & Dohme LLC
 2007-05-23 PHASE4
NCT00449956 COMPLETED
Glaucoma
Merck Sharp & Dohme LLC
 2007-03-12 PHASE3
NCT00576342 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2007-12 PHASE3
NCT00906594 COMPLETED
Glaucoma
University of Sao Paulo
 2007-09 PHASE4
NCT00397241 COMPLETED
Open-angle Glaucoma
Aristotle University Of Thessaloniki
 2006-09 PHASE4
NCT00546286 COMPLETED
Glaucoma; Ocular Hypertension
Merck Sharp & Dohme LLC
 2006-05-31 PHASE3
NCT00314171 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Alcon Research
 2005-10 PHASE3
NCT01062971 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension
Laboratorios Sophia S.A de C.V.
 2006-02 PHASE2
NCT00675207 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension
Northwestern Ophthalmic Institute S.C.
 2006-01 PHASE4
NCT00333125 COMPLETED
Glaucoma; Ocular Hypertension
Alcon Research
 2006-04 PHASE3
NCT00822055 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Allergan
 2005-05 PHASE4
NCT00108017 COMPLETED
Glaucoma; Ocular Hypertension
Merck Sharp & Dohme LLC
 2005-04 PHASE3
NCT00822081 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Bp Consulting, Inc
 2005-01 PHASE4
NCT01655758 COMPLETED
Ocular Hypertension
University of Parma
 2002-01 PHASE4
NCT00991822 COMPLETED
Glaucoma, Open-Angle
Medical University of Vienna
 1999-05 PHASE2; PHASE3
NCT00348400 COMPLETED
Glaucoma
Innovative Medical
 PHASE4
NCT00273429 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Pharmaceutical Research Network
 2005-04 PHASE4
NCT00152932 UNKNOWN
Glaucoma
University Health Network, Toronto
 2005-05
NCT00273442 COMPLETED
Ocular Hypertension; Open-Angle Glaucoma; Exfoliation Syndrome; Glaucoma, Pigmentary
Pharmaceutical Research Network
 2005-11 PHASE4
NCT00273481 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Pharmaceutical Research Network
 2005-09 PHASE4
NCT00140049 COMPLETED
Glaucoma, Open Angle; Ocular Hypertension
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2005-07 PHASE4
NCT00273455 COMPLETED
Open-Angle Glaucoma
Pharmaceutical Research Network
 2006-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-07-08)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dorzolamide hydrochloride potently binds to human carbonic anhydrase II and IV, suppressing the enzyme-catalyzed hydration of carbon dioxide and subsequent bicarbonate production in ocular tissues. This enzymatic inhibition reduces the secretion of aqueous humor by the ciliary processes, thereby lowering intraocular pressure in clinical conditions such as 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.