Clinical Trial

A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE

Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated June 22, 2026 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
rhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-08-05; most recent amendment 2026-06-17.
Status change: Active, Not Recruiting → Recruiting 2025-10-01
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-09-24
Trial Details
NCT Number NCT07118241
Lead Sponsor Lubris Bio Pty Ltd
Conditions Sjögren's Syndrome
Enrollment 80 participants
Start Date 2025-09-17
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-22