Clinical Trials

Brimonidine tartrate has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, primarily targeting ophthalmic and vascular conditions such as open-angle glaucoma, ocular hypertension, myopia, presbyopia, intraoperative floppy iris syndrome, and capillary malformations. Sponsored by academic medical centers, healthcare foundations, and industry partners including Allergan and the Medical University of Vienna, these studies investigate monotherapy and combination formulations to manage intraocular pressure and ocular physiology. Across these evaluations, recruitment statuses range from completed and currently recruiting to terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04007276 NOT_YET_RECRUITING
Glaucoma; Glaucoma, Open-Angle; Glaucoma; Drugs; Droopy Eyelid; Ptosis; Glaucoma, Primary Open Angle
Tulane University
 2026-11-10 PHASE4
NCT07390578 NOT_YET_RECRUITING
Acquired Ptosis
Duke University
 2026-12-01 PHASE4
NCT07690397 ACTIVE_NOT_RECRUITING
Primary Open-Angle Glaucoma (POAG); Ocular Hypertension
Tecnoquimicas
 2026-06-10 PHASE4
NCT06365853 ACTIVE_NOT_RECRUITING
Recurrent Ovarian Cancer; Folate Receptor-Alpha Positive
AbbVie
 2024-07-29 PHASE2
NCT07209410 RECRUITING
Glaucoma
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
 2025-11-01 PHASE4
NCT07082764 NOT_YET_RECRUITING
Chemotherapy Induced Peripheral Neuropathy
Tarian Pharma
 2025-09-01 PHASE2
NCT06818058 RECRUITING
EGFR Inhibitor-associated Rash
Tarian Pharma
 2025-01-20 PHASE2
NCT06996236 NOT_YET_RECRUITING
Myopia
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
 2025-07 PHASE2
NCT06948357 RECRUITING
Presbyopia
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
 2025-03-24 PHASE2
NCT06449352 COMPLETED
Normal Tension Glaucoma
Westlake Eye Specialists
 2024-06-13 PHASE4
NCT07431476 COMPLETED
Rosacea; Rosacea Subtype 1 (Erythematotelangiectatic)
Istanbul Training and Research Hospital
 2025-05-01 PHASE4
NCT06803654 COMPLETED
Ocular Redness
Bausch & Lomb Incorporated
 2025-05-22 PHASE3
NCT03193333 TERMINATED
Primary Open-angle Glaucoma
Laboratorios Sophia S.A de C.V.
 2017-11-06 PHASE3
NCT06730516 COMPLETED
Glaucoma
Zagazig University
 2024-06-24 EARLY_PHASE1
NCT06045299 COMPLETED
Presbyopia; Near Vision; Miosis; Eye Diseases
Corxel Pharmaceuticals
 2023-09-27 PHASE3
NCT05480098 WITHDRAWN
Dermatochalasis of Eyelid; Ptosis, Eyelid; Ectropion; Entropion
University of Louisville
 2022-05-26 PHASE4
NCT06270030 COMPLETED
Presbyopia
Corxel Pharmaceuticals
 2024-03-04 PHASE1
NCT05753189 COMPLETED
Presbyopia; Near Vision; Refractive Error; Eye Diseases
LENZ Therapeutics, Inc
 2023-02-21 PHASE3
NCT05656027 COMPLETED
Presbyopia; Refractive Error; Eye Diseases; Near Vision
LENZ Therapeutics, Inc
 2022-12-19 PHASE3
NCT05728944 COMPLETED
Presbyopia; Near Vision; Refractive Error; Eye Diseases
LENZ Therapeutics, Inc
 2023-03-06 PHASE3
NCT04702789 TERMINATED
Glaucoma, Open-Angle; Ocular Hypertension
Laboratorios Sophia S.A de C.V.
 2021-10-19 PHASE4
NCT05936489 COMPLETED
Eye Diseases; Presbyopia; Refractive Errors; Brimonidine Tartrate; Aceclidine; Ophthalmic Solutions
LENZ Therapeutics, Inc
 2023-07-06 PHASE1
NCT05815758 COMPLETED
Allergic Conjunctivitis
Bausch & Lomb Incorporated
 2023-04-20 PHASE3
NCT05591755 COMPLETED
Seasonal Allergic Conjunctivitis
Bausch & Lomb Incorporated
 2022-11-18 PHASE3
NCT05579730 COMPLETED
Allergic Conjunctivitis
Bausch & Lomb Incorporated
 2022-10-12 PHASE3
NCT05270863 COMPLETED
Presbyopia
Visus Therapeutics
 2022-03-30 PHASE3
NCT05431543 COMPLETED
Presbyopia; Refractive Errors; Eye Diseases
LENZ Therapeutics, Inc
 2022-08-06 PHASE2
NCT05360784 COMPLETED
Ocular Redness
Bausch & Lomb Incorporated
 2022-05-13 PHASE3
NCT03220490 UNKNOWN
Glaucoma; Glaucoma; Drugs
Sheba Medical Center
 2017-11-01
NCT05401422 UNKNOWN
Rosacea
Cairo University
 2022-05-25
NCT05294328 COMPLETED
Presbyopia; Refractive Errors; Eye Diseases
LENZ Therapeutics, Inc
 2022-05-05 PHASE2
NCT04944290 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Padagis LLC
 2021-05-28 PHASE3
NCT05474716 COMPLETED
Glaucoma, Primary Open Angle; Ocular Blood Flow; Optical Coherence Tomography Angiography
Fayoum University
 2020-05-01 PHASE4
NCT05006911 UNKNOWN
Presbyopia
Optall Vision
 2021-08-14 PHASE1
NCT05001243 UNKNOWN
Presbyopia
Optall Vision
 2021-08-10 PHASE1
NCT04683159 UNKNOWN
Pterygium; Subconjunctival Hemorrhage
Uptown Eye Specialists
 2021-02
NCT04647461 UNKNOWN
Glaucoma; Ocular Hypertensive
CHA University
 2019-03-20 PHASE4
NCT03450629 COMPLETED
Open Angle Glaucoma; Ocular Hypertension
Sun Pharma Advanced Research Company Limited
 2018-09-13 PHASE3
NCT03760185 COMPLETED
Intraoperative Floppy Iris Syndrome
Denver Health and Hospital Authority
 2019-01-04 PHASE2
NCT04523844 COMPLETED
Eye Diseases; Injection Complication; Intraocular Pressure
General Hospital of Athens Elpis
 2020-05-11
NCT05006898 COMPLETED
Presbyopia
Optall Vision
 2020-06-01 PHASE1
NCT03591874 TERMINATED
Graft Versus Host Disease; Ocular Surface Disease; oGVHD; Ocular Graft vs Host Disease; Brimonidine Tartrate; Lubricant Eye Drops; Ophthalmic Solutions; Graft vs Host Disease
Ocugen
 2018-12-23 PHASE3
NCT03782701 COMPLETED
Eyelid Droop
University of Miami
 2019-06-18 PHASE4
NCT04205201 COMPLETED
To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients
Chittagong Medical College
 2018-06-25 PHASE2
NCT03825081 UNKNOWN
Presbyopia; Pseudophakia
Massachusetts Eye and Ear Infirmary
 2019-01-21 EARLY_PHASE1
NCT04633954 COMPLETED
Subconjunctival Hemorrhage; Cataract Surgery
Uptown Eye Specialists
 2019-06-06
NCT03959176 COMPLETED
Intraocular Pressure
Wake Forest University Health Sciences
 2019-07-20 PHASE4
NCT03497442 COMPLETED
Flushing; Alcohol-Related Disorders; Aldehyde Dehydrogenase Deficiency
University of California, San Francisco
 2018-07-12 EARLY_PHASE1
NCT03785340 COMPLETED
Dry Eye
Ocugen
 2018-12-03 PHASE3
NCT02623023 WITHDRAWN
Ocular Hypertension
McMaster University
 2019-01-01
NCT03173365 TERMINATED
Hand-foot Syndrome
Heinrich-Heine University, Duesseldorf
 2017-07-10 PHASE2
NCT03323164 COMPLETED
Glaucoma; Drugs; Normal Tension Glaucoma; Primary Open-angle Glaucoma
Wills Eye
 2017-07-10 PHASE4
NCT02764411 TERMINATED
Capillary Malformations
The Hospital for Sick Children
 2016-06 PHASE3
NCT02863705 COMPLETED
Glaucoma, Open-Angle; Normal Tension Glaucoma
Allergan
 2016-07-05 PHASE4
NCT02730871 TERMINATED
Open-angle Glaucoma; Ocular Hypertension
Alcon Research
 2016-06-24 PHASE4
NCT02087085 TERMINATED
Geographic Atrophy; Macular Degeneration
Allergan
 2014-05-09 PHASE2
NCT03418727 COMPLETED
Dry Eye
Ocugen
 2017-09-06 PHASE2
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
NCT02967614 COMPLETED
Glaucoma; Eye Diseases; Ocular Hypertension
Kukje Pharma
 2016-12 PHASE1
NCT03139708 COMPLETED
Intraocular Pressure
Wake Forest University Health Sciences
 2016-09 PHASE1
NCT03508869 TERMINATED
Erythema and Flushing Associated With Rosacea
Skin Laser & Surgery Specialists
 2016-09-27
NCT03513172 COMPLETED
Post-Injection Intraocular Pressure Spikes
University of Toronto
 2016-12-15
NCT03192826 COMPLETED
Posterior Capsule Opacification; Ocular Hypertension
University Hospital of Patras
 2016-06-20 PHASE4
NCT03048058 COMPLETED
Rosacea
Wake Forest University Health Sciences
 2016-05-05 PHASE4
NCT02975557 TERMINATED
Dry Eye; Ocular Graft vs Host Disease; Meibomian Gland Dysfunction
Sandeep Jain, MD
 2016-05 PHASE1; PHASE2
NCT02856919 COMPLETED
Chronic Persistent Vascular Facial Erythema
Galderma Brasil Ltda.
 2016-06-13 PHASE4
NCT02818816 COMPLETED
Prostate Cancer
University Health Network, Toronto
 2016-02-29 PHASE4
NCT02770248 COMPLETED
Glaucoma
Alcon Research
 2016-05-23 PHASE4
NCT02339584 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2015-04-14 PHASE3
NCT02616250 COMPLETED
Rosacea
Galderma R&D
 2015-12 PHASE4
NCT02568111 WITHDRAWN
Relapsing-Remitting Multiple Sclerosis (RRMS)
Biogen
 2016-02 PHASE4
NCT02214680 UNKNOWN
Healthy
Carmel Medical Center
 2015-10 PHASE2
NCT02761174 COMPLETED
Telangiectasias
Merete Haedersdal
 2016-03-13 PHASE4
NCT02385240 COMPLETED
Rosacea
Padagis LLC
 2015-03 PHASE3
NCT01726075 COMPLETED
Diabetic Retinopathy
BCN Peptides
 2013-02 PHASE2; PHASE3
NCT02249065 COMPLETED
Rosacea
Galderma R&D
 2014-09 PHASE4
NCT03966560 COMPLETED
Glaucoma, Open-Angle
Afyon Kocatepe University Hospital
 2014-01 PHASE4
NCT02147691 COMPLETED
Acne Rosacea
Derm Research, PLLC
 2014-05 PHASE4
NCT02289352 COMPLETED
Rosacea
Actavis Inc.
 2014-07 PHASE3
NCT00275756 WITHDRAWN
Glaucoma
Medical University of Vienna
 2008-09
NCT00712777 WITHDRAWN
Ocular Physiology; Intraocular Pressure
Medical University of Vienna
 2008-03
NCT01217606 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Allergan
 2011-01 PHASE3
NCT01284166 WITHDRAWN
Glaucoma; Ocular Hypertension
Allergan
 2013-07 PHASE3
NCT01937312 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Alcon Research
 2013-10 PHASE4
NCT01959243 COMPLETED
Hyperemia
Bausch & Lomb Incorporated
 2014-02-22 PHASE3
NCT01937299 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Alcon Research
 2013-10 PHASE4
NCT02039765 COMPLETED
Hyperemia
Bausch & Lomb Incorporated
 2014-02 PHASE1
NCT01978600 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2013-10 PHASE4
NCT01080209 COMPLETED
Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Allergan
 2010-02 PHASE2
NCT02140450 COMPLETED
Intraocular Pressure Change in Intravitreal Injection
Mashhad University of Medical Sciences
 2012-02
NCT01959230 COMPLETED
Hyperemia
Bausch & Lomb Incorporated
 2013-11-07 PHASE3
NCT01863953 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2013-06 PHASE2
NCT01885000 COMPLETED
Rosacea; Erythema
Galderma R&D
 2013-07-01 PHASE3
NCT01201551 COMPLETED
Primary Vascular Dysregulation
University Hospital, Basel, Switzerland
 2011-06
NCT01241240 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Allergan
 2011-03 PHASE3
NCT01415401 COMPLETED
Glaucoma; Ocular Hypertension; Open-angle Glaucoma
Alcon Research
 2011-09 PHASE4
NCT00869141 COMPLETED
Glaucoma
University of California, Los Angeles
 2009-03 PHASE4
NCT01518244 COMPLETED
Glaucoma
Alcon Research
 2011-12 PHASE4
NCT02003534 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Allergan
 2010-07 PHASE4
NCT01310777 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-05 PHASE3
NCT01309204 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-05 PHASE3
NCT01687426 COMPLETED
Glaucoma and Ocular Hypertension
Eye Therapies, LLC
 2012-09 PHASE1
NCT01675609 COMPLETED
Ocular Redness
Eye Therapies, LLC
 2012-08 PHASE2
NCT01525173 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2012-01 PHASE4
NCT01105065 COMPLETED
Glaucoma
Massachusetts Eye and Ear Infirmary
 2010-03
NCT01514734 TERMINATED
Glaucoma
Alcon Research
 2012-03 PHASE4
NCT01216943 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2010-11 PHASE3
NCT00824824 COMPLETED
Glaucoma
Massachusetts Eye and Ear Infirmary
 2009-01
NCT01297920 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-03 PHASE3
NCT01297517 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-02 PHASE3
NCT01151904 TERMINATED
Glaucoma, Angle-Closure
Allergan
 2009-11 PHASE4
NCT00800540 COMPLETED
Glaucoma
Alcon Research
 2009-02 PHASE4
NCT01417858 UNKNOWN
Glaucoma, Narrow Angle
Universidade Federal do Paraná
 2010-11
NCT01426867 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2011-09 PHASE2
NCT01144494 COMPLETED
Intraocular Pressure
University of Nebraska
 2010-08-01 EARLY_PHASE1
NCT01229462 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2010-10
NCT01446497 UNKNOWN
Normal Tension Glaucoma
Seoul National University Hospital
 2010-10 PHASE4
NCT01345448 UNKNOWN
Glaucoma
Nanduri, Padma, M.D., FACS
 2011-04 PHASE2
NCT01229410 COMPLETED
Vitrectomy
Allergan
 2010-12 PHASE1
NCT01275105 COMPLETED
Allergic Conjunctivitis
Eye Therapies, LLC
 2011-01 PHASE2
NCT01004900 UNKNOWN
Glaucoma
Singapore Eye Research Institute
 2009-06 PHASE3
NCT00693485 COMPLETED
Glaucoma, Open-Angle
Allergan
 2008-09 PHASE2
NCT00972374 COMPLETED
Rhegmatogenous Macula-off Retinal Detachment
Allergan
 2009-11 PHASE2
NCT01170884 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2009-12 PHASE4
NCT00981786 COMPLETED
Glaucoma
Aristotle University Of Thessaloniki
 2009-08 PHASE4
NCT00706927 COMPLETED
Retina; Ocular Physiology
Medical University of Vienna
 2006-01
NCT00658619 COMPLETED
Macular Degeneration
Allergan
 2008-05-01 PHASE2
NCT00961649 TERMINATED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2009-10 PHASE2
NCT00800423 UNKNOWN
Corneal Edema; Visual Acuity
Rabin Medical Center
 2009-01 PHASE3
NCT00811564 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2008-12 PHASE4
NCT00811850 COMPLETED
Glaucoma
Allergan
 2008-12 PHASE4
NCT00661479 COMPLETED
Retinitis Pigmentosa
Allergan
 2008-07 PHASE1; PHASE2
NCT00735449 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2008-07 PHASE4
NCT00972257 COMPLETED
Glaucoma
Aristotle University Of Thessaloniki
 2009-01 PHASE4
NCT00864838 COMPLETED
Age Related Macular Degeneration; Diabetic Retinopathy
University of Sao Paulo
 2008-06 PHASE2
NCT00457795 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Allergan
 2006-12 PHASE4
NCT00698945 COMPLETED
Ocular Hypertension; Open-Angle Glaucoma
Bp Consulting, Inc
 2008-06 PHASE4
NCT00697541 COMPLETED
Erythematous Rosacea
Galderma R&D
 2008-05 PHASE2
NCT00402493 COMPLETED
Glaucoma; Ocular Hypertension
Philadelphia Eye Associates
 2006-12
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
NCT00440141 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2006-07 PHASE4
NCT00651612 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2005-11 PHASE3
NCT00822055 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Allergan
 2005-05 PHASE4
NCT00168363 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2005-01 PHASE3
NCT00822081 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Bp Consulting, Inc
 2005-01 PHASE4
NCT00061529 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Alcon Research
 2003-01 PHASE3
NCT00652106 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2003-06 PHASE3
NCT00652483 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2003-05 PHASE3
NCT00332436 COMPLETED
Ocular Hypertension
Allergan
 1999-12 PHASE3
NCT00332384 COMPLETED
Ocular Hypertension
Allergan
 2000-01 PHASE3
NCT00332345 COMPLETED
Ocular Hypertension
Allergan
 1999-07 PHASE2
NCT00466479 COMPLETED
Glaucoma
University of Parma
 1999-08 PHASE4
NCT00804921 COMPLETED
Macular Edema; Diabetic Retinopathy; Macular Degeneration
University of Sao Paulo
 PHASE2
NCT00352807 COMPLETED
Cataract
Indiana University
 2005-02
NCT00348400 COMPLETED
Glaucoma
Innovative Medical
 PHASE4
NCT00435058 COMPLETED
Glaucoma
University of Sao Paulo
 2005-09
NCT00567411 UNKNOWN
Glaucoma; Ocular Hypertension
Walter Reed Army Medical Center
 2006-08
NCT00347035 TERMINATED
Glaucoma
Federal University of São Paulo
 PHASE4
NCT00312416 COMPLETED
Ocular Physiology; Regional Blood Flow
Medical University of Vienna
 2004-02 PHASE4
NCT00442312 UNKNOWN
Glaucoma
Genovate Biotechnology Co., Ltd.,
 2006-05 PHASE4
NCT00121147 COMPLETED
Open Angle Glaucoma; Ocular Hypertension; Pseudoexfoliation Syndrome
Hermann Eye Center
 2003-09
NCT00317577 COMPLETED
Glaucoma, Open Angle
Chicago Center for Vision Research
 1998-12 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-10-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brimonidine tartrate is a highly selective alpha-2 adrenergic receptor agonist that binds to and activates alpha-2A adrenoreceptors to inhibit adenylate cyclase, thereby reducing intracellular cyclic AMP levels, suppressing aqueous humor production, and enhancing uveoscleral outflow. This cellular response directly lowers intraocular pressure, establishing its therapeutic efficacy in managing clinical trial 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.