Nepafenac Clinical Trials

Size	Price	Qty
10mg	USD 79

Clinical Trials

Multiple completed clinical trials have evaluated nepafenac for ophthalmic applications, primarily targeting ocular pain and cataract-related indications. Sponsored by both academic institutions, such as the University Hospital of Patras, and commercial entities, including MDbackline LLC and Alcon Research, these trials carry phase classifications designated as not applicable. Specific protocols assessed the analgesic efficacy of topical nepafenac 0.1% for intravitreal injection pain, as well as the tolerability and safety of nepafenac 0.3% relative to ketorolac.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02821390	Completed	Pain	University Hospital of Patras	2016-06	Not Applicable
NCT02752646	Completed	Cataract	MDbackline LLC\|Alcon Research	2016-04	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nepafenac is a prodrug that is bioactivated to amfenac, which potently inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, thereby suppressing downstream prostaglandin biosynthesis and reducing local intraocular inflammatory cascades. This targeted enzymatic inhibition decreases vascular permeability and cellular mediator release, directly attenuating ocular pain and inflammation associated with cataract surgery and ophthalmic 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>).