A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EF
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.
| Condition(s) | Sjögren's Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Have the ability to comprehend and provide a signed and dated consent form. 2. Are 18-75 years at time of consent; 3. Have been diagnosed with SS for at least 3 months prior to ICF; 4. Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1; 5. Have been stably using systemic medications for at least one month prior to Visit 1; 6. Have Global SANDE score ≥ 40; 7. Average VAS score for typical symptoms of dry eye (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none \< 5 mm; 8. Have Oxford corneal fluorescein staining grade of ≥ 1 and ≤ 2 in each eye (OD \& OS both ≥ 1 and ≤ 2); 9. Stated willingness to comply with all study proc |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Lubris Bio Pty Ltd |
| Locations | Sydney, New South Wales, Australia; Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Brisbane, Queensland, Australia; Maroochydore, Queensland, Australia; Melbourne, Victoria, Australia |
| Start date | 2025-09-17 |
| NCT ID | NCT07118241 |
| Official listing | https://clinicaltrials.gov/study/NCT07118241 |