drugset / Trial / NCT07118254
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
RandomizedCrossoverQuadruple-blindTreatment
Summary
An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period.
Timeline
- Start
- 2025-09-17
- Primary completion
- 2026-09
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhPRG4 | Protein / enzyme biologic | 450 ug/ml | — |