A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects
Summary
The objective of this study is to evaluate the safety and effectiveness of topical KIO-201 in patients with persistent corneal epithelial defects (PED). KIO-201 will be administered six (6) times per day while awake for 4 weeks. The primary exploratory effectiveness outcome for this study is the percentage of patients achieving corneal healing as determined by corneal fluorescein staining and photos. The effectiveness endpoint will be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis.
Timeline
- Start
- 2022-07-01
- Primary completion
- 2022-12-22
- Completion
- 2023-01-22
Outcome
Met primary endpoint
release “KIO-201 resulted in > 90.0% reduction in defect size at 4 weeks post treatment initiation. 5 of 8 patients (62.5%) achieved the primary endpoint” kiorapharma.com ↗
release “KIO-201 achieved a 90.0% mean reduction in defect size four weeks after treatment (p<0.003), while 5 of 8 patients (62.5%) achieved the primary endpoint” kiorapharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KIO-201 | Other / unclassified | 0.75 % | Topical |