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)

NCT07118254 ↗

Phase 2 Recruiting 15 enrolled Lubris Bio Pty Ltd
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

EvaluationDrugModalityDoseRoute
Subject rhPRG4 Protein / enzyme biologic 450 ug/ml —