NCT06520202

RHPRG4 FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Lubris Bio Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A 1-day, randomized (1:1) controlled, masked, pre-market study. Subjects with moderate to severe Sjögren's related Dry Eye Disease will be evaluated at 0, 5, 30 \& 90 minutes post dose of either rhPRG4 (Treatment group) or vehicle (Crossover group). At 90 minutes, Crossover group subjects will be administered rhPRG4, then evaluated 5 \& 30 minutes after rhPRG4 instillation (95 \& 120 minutes from baseline). All subjects will self-report for the remainder of the day at 4 hours and 8 hours post dose.

Conditions

• Sjogren's Syndrome With Dry Eye

Interventions

Type	Name	Description
DRUG	rhPRG4 (450 µg/mL)	1-2 drops of rhPRG4 450 µg/mL solution in both eyes
DRUG	Vehicle	Sterile isotonic aqueous solution for ocular administration containing 0.01% polysorbate 20.

Timeline

• Start date: 2024-11-05
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2024-07-25
• Last updated: 2025-09-29

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study