Actively Recruiting
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
Led by Lubris Bio Pty Ltd · Updated on 2026-02-05
80
Participants Needed
6
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Age between 18 and 75 years at consent
- Diagnosed with Sjögren's Syndrome for at least 3 months before consent
- Using artificial tears as the only topical treatment for Sjögren's dry eye for at least 30 days before Visit 1
- Stable use of systemic medications for at least one month before Visit 1
- Global SANDE score of 40 or higher
- Average dry eye symptom score (VAS) of 25 mm or more, with no symptom less than 5 mm
- Oxford corneal fluorescein staining grade between 1 and 2 in each eye
- Willingness to comply with all study procedures and attend all visits
- Ability and willingness to self-administer study medication and follow treatment regimen
You will not qualify if you...
- Current or past ocular or systemic disorders (other than dry eye) that interfere with study results, such as active eye infections, conjunctivochalasis, keratoconjunctivitis, corneal dystrophies, blepharitis, ocular trauma, uveitis, or systemic infections
- Use of any topical ocular medications (except artificial tears), therapeutic devices, or ocular surgery within 30 days before Visit 1
- Unwillingness to avoid topical medications (other than study medication and limited artificial tears), devices, or surgery from Visit 1 to Visit 4
- Having only one eye
- Unwillingness to apply vehicle drops three times daily during run-in
- Unwillingness to limit artificial tear use to no more than 4 days during run-in
- Starting systemic compounds for Sjögren's or related dry eye within one month before Visit 1 (including omega-3, corticosteroids, immunosuppressants, biologics)
- Unwillingness to maintain stable systemic compound use during the study
- Known allergy to study or procedural medications
- Participation in another clinical study concurrently or within 30 days before Visit 1
- History of drug, medication, or alcohol abuse
- Females of childbearing potential who are pregnant, breastfeeding, plan pregnancy during study and 30 days after, or unwilling to use effective birth control
- Males with female partners of childbearing potential not surgically sterilized or unable to confirm partner's status
- History of serious physical or psychiatric disorders that affect study participation
- Other medical or surgical conditions that compromise safety or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Sydney Eye Hospital
Sydney, New South Wales, Australia
Not Yet Recruiting
2
Univ of New South Wales
Sydney, New South Wales, Australia
Actively Recruiting
3
OTA
Brisbane, Queensland, Australia
Actively Recruiting
4
Queensland University of Technology
Brisbane, Queensland, Australia
Actively Recruiting
5
University of the Sunshine Coast
Maroochydore, Queensland, Australia
Actively Recruiting
6
University of Melbourne
Melbourne, Victoria, Australia
Actively Recruiting
Research Team
E
Edward CEO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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