Phase 2: testing Recombinant Human Proteoglycan 4 for Sjögren's Syndrome
RhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to measure the safety and how well it works of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.
Official registry: https://clinicaltrials.gov/study/NCT07118241 · Lubris Bio Pty Ltd · enrollment listed as 80
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Recombinant Human Proteoglycan 4, or Vehicle Control. The registry lists allocation as randomized. RhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to measure the safety and how well it works of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.
They plan to enroll about 80 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Recombinant Human Proteoglycan 4, Vehicle Control
Primary outcome (registry wording): To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28
Who it is for (from inclusion criteria)
- Ages 18 Years to 80 Years
- Have the ability to comprehend and provide a signed and dated consent form
- Are 18-75 years at time of consent;
- Have been diagnosed with SS for at least 3 months prior to ICF;
- Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;
- Have been stably using systemic medications for at least one month prior to Visit 1;
- Have Global SANDE score ≥ 40;
- 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;
Who the registry excludes
- Are unwilling to forgo the use of topical medications (other than IMP and limited artificial tear use), medical devices or ocular surgery from Visit 1 through Visit 4
- Are unwilling to adhere to t.i.d. administration of vehicle during run-in;
- Are unwilling to limit the use of artificial tears to no more than 4 days during run-in;
- Are unwilling to maintain a stable regimen of systemic compound use during the duration of the study;
- Have known hypersensitivity to one of the components of the study or procedural medications;
- Have participated in another clinical study at the same time as the present study or within 30 days of Visit 1;
- Have a history of drug, medication or alcohol abuse or addiction;
Public study contact (from the registry)
Edward CEO
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
7 listed- Sydney Eye Hospital — Sydney, New South Wales, Australia (recruiting)
- Univ of New South Wales — Sydney, New South Wales, Australia (recruiting)
- OTA — Brisbane, Queensland, Australia (recruiting)
- Queensland University of Technology — Brisbane, Queensland, Australia (recruiting)
- University of the Sunshine Coast — Maroochydore, Queensland, Australia (recruiting)
- The Royal Melbourne Hospital — Melbourne, Victoria, Australia (recruiting)
- University of Melbourne — Melbourne, Victoria, Australia (recruiting)
FAQ about this NCT record
Is NCT07118241 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07118241?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07118241?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary