Actively Recruiting
A Phase II Randomized, Double-Masked Study Comparing rhPRG4 (450 g/ml Recombinant Human Proteoglycan 4) to Vehicle for Treating Sj f6gren's Related Dry Eye Disease
Led by Lubris Bio Pty Ltd · Updated on 2026-02-05
80
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of a topical treatment called recombinant human proteoglycan 4 (rhPRG4) in people with Sjögren's related Dry Eye Disease. The study is a phase II, prospective, randomized, and double-masked trial conducted across multiple centers in Australia. It focuses on improving symptoms and healing the eye surface in adults diagnosed with Sjögren's Syndrome who experience dry eye symptoms. Participants will be randomly assigned to receive either rhPRG4 at a concentration of 450 micrograms per milliliter or a placebo vehicle control. The treatment is applied topically to the eyes, and the study lasts 28 days. The trial compares the effects of rhPRG4 with the placebo to assess its impact on corneal damage and dry eye symptoms. During the study, participants will attend scheduled clinic visits where researchers will examine their eyes using fluorescein staining to measure corneal healing and perform other eye assessments such as slit lamp examination and intraocular pressure checks. Symptoms like dryness, burning, itching, and blurred vision will be recorded using questionnaires and visual scales. Safety will be closely monitored by observing any adverse events and changes in vision. The total study duration for each participant is 28 days from baseline to end of treatment.
CONDITIONS
Brief 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 provide written informed consent
- Age between 18 and 75 years at consent
- Diagnosed with Sj�f6gren's Syndrome for at least 3 months before consent
- Using only artificial tears for Sj�f6gren's related dry eye for at least 30 days before first visit
- Stable use of systemic medications for at least one month before first visit
- Global SANDE score of 40 or higher
- Average VAS score of at least 25 mm for typical dry eye symptoms, with no symptom below 5 mm
- Oxford corneal fluorescein staining grade between 1 and 2 in each eye
- Willingness to comply with study procedures and attend all visits
- Ability and willingness to self-administer study medication and follow regimen
You will not qualify if you...
- Current or history of ocular or systemic disorders other than dry eye that may affect study results
- Use of topical ocular medications other than artificial tears, therapeutic devices, or ocular surgery within 30 days before first visit
- Unwillingness to stop other topical medications, devices, or surgery use during study
- Having only one eye
- Unwillingness to follow three-times-daily administration during run-in
- Unwillingness to limit artificial tear use to no more than 4 days during run-in
- Starting systemic treatments for Sj�f6gren's or related dry eye within one month before first visit
- Unwillingness to maintain stable systemic treatment during study
- Known allergy to study or procedural medications
- Participation in another clinical trial within 30 days before first visit
- History of drug, medication, or alcohol abuse
- Females of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective birth control during and 30 days after treatment
- Males with female partners of childbearing potential not surgically sterilized or unable to confirm partner's status
- Serious physical or psychiatric disorder that may affect study participation
- Any other medical or surgical condition that may compromise safety or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive either rhPRG4 or a vehicle control to treat Sjögren's related dry eye disease.
Multiple visits during the 28-day treatment period
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here