Clinical Trials
Multiple clinical trials evaluate olopatadine hydrochloride across ocular and nasal allergic conditions, including seasonal allergic conjunctivitis to ragweed, allergic rhinitis, and general allergic conjunctivitis. These Phase 2 and unassigned-phase investigations encompass both completed and terminated studies sponsored by entities such as Mati Therapeutics Inc., Vanderbilt University Medical Center, and the University of Wisconsin-Madison in collaboration with the National Eye Institute. Collectively, these trials focus on determining the clinical efficacy, safety, and inflammatory mediator dynamics associated with these allergic manifestations.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01287338 | Terminated | Seasonal Allergic Conjunctivitis to Ragweed |
Mati Therapeutics Inc. |
2010-10 | Phase 2 |
| NCT00775658 | Completed | Allergic Rhinitis|Allergic Conjunctivitis |
Vanderbilt University Medical Center |
2008-01 | Not Applicable |
| NCT00609128 | Completed | Allergic Conjunctivitis |
University of Wisconsin Madison|National Eye Institute (NEI) |
2000-09 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
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>).