Actively Recruiting
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Led by Lubris Bio Pty Ltd · Updated on 2026-01-20
15
Participants Needed
3
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period.
CONDITIONS
Official Title
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and provide signed consent
- Age between 18 and 80 years at consent
- Diagnosed with ocular graft-versus-host disease for at least 3 months
- Currently using artificial tears for oGVHD-related dry eye
- Stable systemic medication use for at least 14 days before first visit
- Eye dryness score of at least 40 mm on a 100-point scale
- Average visual analog scale score for dry eye symptoms of at least 25 mm, with no symptom below 5 mm
- Oxford corneal fluorescein staining grade of 2 or higher in the worse eye
- Willingness to comply with all study procedures and attend all visits
- Ability and willingness to self-administer study medication and follow dosing schedule
You will not qualify if you...
- Current or past ocular or systemic conditions other than dry eye that could affect study results, including active eye infections, conjunctivochalasis, keratoconjunctivitis forms, stem cell deficiency, allergic conjunctivitis, corneal dystrophies, blepharitis, ocular trauma, uveitis, or systemic infection
- Eye surgery or use of therapeutic eye devices in either eye within 30 days before enrollment; eye surgery prohibited during study
- Starting new therapeutic treatments within 14 days before first visit
- Known allergy to any study or procedural medication components
- Participation in another clinical study concurrently or within 30 days before first visit
- History of drug, medication, or alcohol abuse
- Female participants of childbearing potential who are pregnant, breastfeeding, have positive pregnancy test, plan pregnancy during or 30 days after study, or unwilling to use effective contraception
- Serious physical or mental disorder preventing study compliance or decision-making
- Any medical or surgical condition judged by the investigator to compromise safety or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sydney Eye Hospital
Sydney, New South Wales, Australia
Not Yet Recruiting
2
OTA
Brisbane, Queensland, Australia
Actively Recruiting
3
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Actively Recruiting
Research Team
E
Edward CEO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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