Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the utility, safety, and pharmacokinetics of tafluprost—as both a preservative-free monotherapy and a fixed-dose combination with timolol—for primary open-angle glaucoma, ocular hypertension, and ocular surface disease. Sponsored by major pharmaceutical companies and academic institutions, the majority of these studies are completed, whereas others have been terminated or remain in an unknown recruitment standing.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03822559 COMPLETED
Open-angle Glaucoma, Ocular Hypertension
Santen Pharmaceutical Co., Ltd.
 2019-01-20 PHASE3
NCT05299593 UNKNOWN
Glaucoma, Open-Angle; Ocular Hypertension
Fondazione G.B. Bietti, IRCCS
 2020-06-04 PHASE4
NCT04828057 Completed
Ocular Surface Disease|Primary Open Angle Glaucoma
Santen Pharmaceutical (Taiwan) Co. LTD
 2021-09-01 --
NCT04654611 COMPLETED
Glaucoma; Primary Open Angle Glaucoma; Ocular Hypertension
Tun Hussein Onn National Eye Hospital
 2019-02-01 PHASE4
NCT03595865 UNKNOWN
Glaucoma; Drugs
wangdabo
 2018-08-01
NCT04737928 COMPLETED
Glaucoma, Primary Open Angle
Santen Pharmaceutical (Taiwan) Co., LTD
 2018-04-02
NCT04455126 COMPLETED
Glaucoma
Alexandria University
 2018-04-01 PHASE2; PHASE3
NCT03612817 COMPLETED
Glaucoma, Open-Angle
Aristotle University Of Thessaloniki
 2017-01 PHASE4
NCT02102750 COMPLETED
Glaucoma; Ocular Hypertension
Santen Oy
 2014-06 PHASE1
NCT02471105 UNKNOWN
Ocular Hypertension; Glaucoma
Universitaire Ziekenhuizen KU Leuven
 2015-09 PHASE4
NCT03204487 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Ordination Dr. Hommer
 2016-05-10 PHASE4
NCT03612817 Completed
Glaucoma Open-Angle
Aristotle University Of Thessaloniki|Santen Oy
 2017-01 Phase 4
NCT02802137 COMPLETED
Glaucoma; Ocular Surface Disease
Aristotle University Of Thessaloniki
 2015-03 PHASE4
NCT03104621 COMPLETED
Primary Open-angle Glaucoma
Gangnam Severance Hospital
 2013-03 PHASE4
NCT02102750 Completed
Glaucoma|Ocular Hypertension
Santen Oy
 2014-06 Phase 1
NCT01979913 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension
Dr. Anton Hommer
 2013-10 PHASE4
NCT01254604 COMPLETED
Glaucoma; Ocular Hypertension
Merck Sharp & Dohme LLC
 2011-12-01 PHASE3
NCT01433900 UNKNOWN
Glaucoma
Paolo Fogagnolo
 2012-05 PHASE3
NCT03104621 Completed
Primary Open-angle Glaucoma
Gangnam Severance Hospital
 2013-03 Phase 4
NCT01654484 COMPLETED
Glaucoma and Ocular Hypertension
Santen Inc.
 2012-07 PHASE1; PHASE2
NCT01342081 COMPLETED
Open Angle Glaucoma; Ocular Hypertension
Santen Pharmaceutical Co., Ltd.
 2011-05 PHASE3
NCT01292460 COMPLETED
Ocular Hypertension; Open-angle Glaucoma
Santen Oy
 2011-02 PHASE3
NCT01369771 COMPLETED
Ocular Hypertension; Open-Angle Glaucoma
FinnMedi Oy
 2010-08 PHASE4
NCT01306461 COMPLETED
Ocular Hypertension; Open-angle Glaucoma
Santen Oy
 2011-03 PHASE3
NCT01162603 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
 2011-03 PHASE4
NCT01263535 TERMINATED
Glaucoma
Sensimed AG
 2010-09 PHASE4
NCT01434888 COMPLETED
Healthy Volunteers
Santen Oy
 2011-09 PHASE1
NCT01087671 COMPLETED
Ocular Hypertension; Open-Angle Glaucoma
Santen Oy
 2010-04 PHASE3
NCT01026831 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Merck Sharp & Dohme LLC
 2010-01-06 PHASE3
NCT00966940 COMPLETED
Glaucoma
Alcon Research
 2009-09 PHASE4
NCT00596791 COMPLETED
Ocular Hypertension; Open-Angle Glaucoma
Santen Oy
 2008-01 PHASE3
NCT00918346 COMPLETED
Open-Angle Glaucoma; Ocular Hypertension
Santen Oy
 2005-09 PHASE3

(data from https://clinicaltrials.gov, updated on 2023-07-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tafluprost functions as a highly selective prostanoid agonist of the fluoroprostaglandin receptor, binding to the receptor to stimulate intracellular signaling and increase uveoscleral outflow of aqueous humor. By enhancing fluid drainage through the ciliary meshwork, it leads to a sustained reduction in intraocular pressure, providing direct therapeutic relevance for managing ocular hypertension and primary open-angle glaucoma.

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.