drugset / Trial / NCT06363292
Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.
Timeline
- Start
- 2024-01-30
- Primary completion
- 2024-05-28
- Completion
- 2024-05-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PRO-231 | Unknown | 0.5 % | Topical |
| Comparator | VIGAMOXI® | Unknown | 0.5 % | Topical |