drugset / Trial / NCT06370585
Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects.
Timeline
- Start
- 2024-05-16
- Primary completion
- 2024-07-25
- Completion
- 2024-11-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexpanthenol | Small molecule | 2 % | Other |
| Comparator | Sodium Hyaluronate | Other / unclassified | 0.15 % | Other |
| Comparator | Sodium Hyaluronate | Other / unclassified | 0.4 % | Other |