Clinical Trial

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)

Recruiting Phase 2
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-05; most recent amendment 2026-01-16.
Status change: Active, Not Recruiting → Recruiting 2026-01-16
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-09-24
Trial Details
NCT Number NCT07118254
Lead Sponsor Lubris Bio Pty Ltd
Conditions Ocular Graft Versus Host Disease
Enrollment 15 participants
Start Date 2025-09-17
Primary Completion 2026-09 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-20