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rhPRG4 in Sjögren's Related Dry Eye Disease
NCT07118241Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Lubris BioPharma
- Modality
- rProtein (Recombinant Protein), Biologic
- Conditions
- dry eye disease (DED)
01
Overview
Phase 2, randomised, double-blind trial in dry eye disease (DED) comparing Vehicle Control with rhPRG4 450ug/ml (2 arms). Primary endpoint: Complete resolution of total corneal staining with fluorescein (Oxford Scale) at 28 days. Started Sep 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Vehicle Control
PBS Based Vehicle Control
rhPRG4 450ug/ml
rhPRG4 450ug/ml
03
Who it enrols
Adults aged 18-75 with Sjögren's syndrome for at least 3 months, using artificial tears as the only topical treatment for dry eye, with specific symptom severity scores (SANDE >= 40, VAS >= 25mm) and Oxford corneal staining grade 1-2.
04
Endpoints
Primary
Complete resolution of total corneal staining with fluorescein (Oxford Scale)
Secondary
Treatment-Emergent Adverse Events
Best Corrected Visual Acuity
Slit Lamp Examination Signs
Intraocular Pressure
Visual Analogue Scale Score for Dry Eye Symptoms
Symptom Assessment in Dry Eye Score
Oxford Staining Score
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