Fluorescein Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several Phase 1, Phase 2, and unclassified clinical trials are currently evaluating fluorescein and related ophthalmic or diagnostic formulations to assess safety, tolerability, and diagnostic utility in healthy subjects and patient cohorts. Sponsored by organizations such as Laboratorios Sophia S.A de C.V., Stanford University, Sunhawk Vision Biotech Inc., and Aston University, these active protocols include studies not yet recruiting. These investigations focus on ocular surface disorders like dry eye disease, corneal erosion, and computer vision syndrome, as well as intraoperative nerve identification in head and neck disorders including pleomorphic adenoma of the parotid and Warthin tumor.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06375343	Not yet recruiting	Dry Eye Disease\|Dry Eye Sensation\|Ocular Surface Disease	Laboratorios Sophia S.A de C.V.	2024-10-30	Phase 1
NCT06379685	Not yet recruiting	Dry Eye\|Dry Eyes Chronic\|Dry Eye Syndromes	Laboratorios Sophia S.A de C.V.	2024-09-30	Phase 1
NCT06054178	Not yet recruiting	Pleomorphic Adenoma of the Parotid\|Warthin Tumor\|Head and Neck Disorder	Stanford University	2024-05	Phase 2
NCT06381986	Not yet recruiting	Corneal Erosion	Sunhawk Vision Biotech Inc.	2024-05	Phase 2
NCT06352541	Not yet recruiting	Healthy	Laboratorios Sophia S.A de C.V.	2024-05-30	Phase 1
NCT06163989	Not yet recruiting	Dry Eye Syndromes\|Computer Vision Syndrome	Aston University	2024-05-01	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluorescein acts as a fluorogenic organic dye that absorbs excitation light in the blue spectrum and emits bright green fluorescence, accumulating in intercellular spaces and disrupted epithelial cell layers. This distinct fluorometric response enables high-contrast optical visualization of mucosal barrier breakdown and anatomical structures, providing diagnostic utility for evaluating dry eye syndromes, corneal erosion, and head and neck neoplasms during intraoperative procedures.

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>).