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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Lubris Bio Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	rhPRG4 450ug/ml	Treatment
DRUG	Vehicle Control	PBS Based Vehicle Control

Timeline

• Start date: 2025-09-17
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2025-08-12
• Last updated: 2026-01-20

Locations

3 sites across 1 country: Australia