Tropicamide Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Several clinical trials evaluate tropicamide across ophthalmic and neurological indications. These include Phase 4 interventional studies on cycloplegia for refraction assessment in pediatric patients with esotropia, refractive errors, and vision disorders, alongside an unassigned phase observational study in CADASIL cohorts. Spanning actively recruiting and completed statuses, these initiatives are led by academic and clinical sponsors, including Islamic Hospital Jordan, Prince of Wales Hospital Sydney, and the University of New South Wales.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06148051	Recruiting	Cadasil	Perminder Sachdev\|Prince of Wales Hospital Sydney\|John Hunter Hospital\|St Vincent''s Hospital - Sydney Australia\|Royal Brisbane and Women''s Hospital\|Melbourne Health\|The University of Queensland\|The University of New South Wales	2023-11-25	--
NCT06077682	Recruiting	Cycloplegia\|Refractive Errors\|Esotropia\|Vision Disorders	Islamic Hospital Jordan\|Jordan University of Science and Technology\|Yarmouk University	2023-09-01	Phase 4
NCT05442801	Completed	Cycloplegia	Islamic Hospital Jordan	2022-03-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tropicamide acts as an anticholinergic agent that selectively inhibits muscarinic acetylcholine receptors, exhibiting preference for the M4 subtype with an IC50 of 8.0 nM, thereby blocking downstream cholinergic signal transduction and parasympathetic signaling in smooth muscle tissues. By preventing acetylcholine-mediated activation of pupillary sphincter and ciliary muscle contraction, this targeted inhibition promotes accommodation paralysis and pupillary dilation, providing clinical utility for objective cycloplegic refraction and the evaluation of refractive errors and ocular disorders.

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>).