Clinical Trials

Multiple clinical trials evaluate diquafosol tetrasodium across Phase 1 through Phase 4 for ocular conditions including dry eye disease, vernal keratoconjunctivitis, meibomian gland dysfunction, diabetic eye complications, and perioperative dry eye management in cataract surgery. Ranging from completed to actively recruiting and prospective evaluations, these studies are sponsored by major pharmaceutical entities like Merck Sharp & Dohme LLC alongside academic institutions such as The University of Hong Kong, Samsung Medical Center, and Zhongshan Ophthalmic Center at Sun Yat-sen University.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06903884 RECRUITING
Vernal Keratoconjunctivitis
The University of Hong Kong
 2026-02-09 PHASE3
NCT07397949 NOT_YET_RECRUITING
Dry Eye Disease (DED); Cataract
Samsung Medical Center
 2026-03 PHASE4
NCT06852105 NOT_YET_RECRUITING
Dry Eye; Tear Break-Up Time
He Eye Hospital
 2025-02-28
NCT07097922 NOT_YET_RECRUITING
Dry Eye
He Eye Hospital
 2025-08-01
NCT07397936 COMPLETED
Dry Eye Disease (DED); Cataract
Samsung Medical Center
 2024-08-01 PHASE4
NCT06537349 UNKNOWN
Dry Eye
He Eye Hospital
 2024-08-15
NCT07297316 COMPLETED
Dry Eye Disease (DED)
Korea University Anam Hospital
 2022-10-03 PHASE4
NCT06427031 COMPLETED
Dry Eye; Dry Eye Syndromes
Taejoon Pharmaceutical Co., Ltd.
 2023-07-14 PHASE3
NCT05383612 UNKNOWN
Dry Eye; Meibomian Gland Dysfunction
Zhongshan Ophthalmic Center, Sun Yat-sen University
 2022-08-05
NCT06146881 UNKNOWN
Dry Eye Disease
Indonesia University
 2022-10-02 PHASE2
NCT04980144 UNKNOWN
Diabetic Eye Problems
He Eye Hospital
 2023-03-03
NCT05193331 UNKNOWN
Diabetic Eye Problems
He Eye Hospital
 2023-04-01
NCT06560580 COMPLETED
Dry Eye Disease
Tianjin Eye Hospital
 2021-11-15
NCT05720754 UNKNOWN
Dry Eye
He Eye Hospital
 2023-04-02
NCT05694026 COMPLETED
Dry Eye
He Eye Hospital
 2023-03-01
NCT05682547 COMPLETED
Diabetic Eye Problems
He Eye Hospital
 2022-12-01
NCT05346783 UNKNOWN
Dry Eye Syndromes
Taejoon Pharmaceutical Co., Ltd.
 2021-10-14 PHASE1; PHASE2
NCT04668118 UNKNOWN
Dry Eye Syndromes; Computer Vision Syndrome; Asthenopia
Peking University Third Hospital
 2021-02-01 PHASE4
NCT04548427 COMPLETED
Dry Eye Disease
Chong Kun Dang Pharmaceutical
 2020-09-22 PHASE3
NCT05456061 COMPLETED
Tear; Dry Eye Syndromes
Yonsei University
 2018-08-01
NCT03640351 COMPLETED
Dry Eye; Cataract Surgery
Yonsei University
 2017-08-15
NCT02608489 COMPLETED
Dry Eye Syndromes
Soonchunhyang University Hospital
 2014-01
NCT00831662 COMPLETED
Dry Eye Disease
Merck Sharp & Dohme LLC
 2009-01 PHASE3
NCT00600288 COMPLETED
Dry Eye Disease
Merck Sharp & Dohme LLC
 2008-01 PHASE3
NCT01381731 TERMINATED
Photorefractive Keratectomy
Merck Sharp & Dohme LLC
 2005-04 PHASE2
NCT00403975 COMPLETED
Dry Eye Disease
Merck Sharp & Dohme LLC
 2004-06 PHASE3
NCT00403715 COMPLETED
Dry Eye Disease
Merck Sharp & Dohme LLC
 2001-02 PHASE3
NCT00404131 COMPLETED
Dry Eye Disease
Merck Sharp & Dohme LLC
 2001-03 PHASE3
NCT00679718 COMPLETED
Dry Eye Disease
Merck Sharp & Dohme LLC
 2000-01 PHASE2
NCT00680108 COMPLETED
Dry Eye Disease
Merck Sharp & Dohme LLC
 1999-09 PHASE2
NCT01101984 COMPLETED
Dry Eye
Santen Pharmaceutical Co., Ltd.
 2010-02

(data from https://clinicaltrials.gov, updated on 2026-04-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diquafosol tetrasodium functions as a selective P2Y2 receptor agonist on the ocular surface, binding to P2Y2 purinergic receptors to stimulate intracellular calcium mobilization and downstream phospholipase C signaling pathways. This molecular cascade promotes fluid and mucin secretion from conjunctival goblet cells and corneal epithelial cells, thereby directly counteracting tear film instability and ocular surface epithelium damage in clinical trial conditions such as dry eye disease and meibomian gland dysfunction.

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.