Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-03 @ 4:15 PM
Study NCT ID:
NCT06520202
Status:
TERMINATED
Last Update Posted:
2025-09-29
First Post:
2024-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RHPRG4 FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sponsor:
Lubris Bio Pty Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Efficacy signal substantial enough to move to a larger sturdy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: