RecruitingPhase 2NCT07118241

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


Sponsor

Lubris Bio Pty Ltd

Enrollment

80 participants

Start Date

Sep 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new eye drop treatment for dry eye disease caused by Sjögren's syndrome, a condition where the immune system attacks the glands that produce tears and saliva. The trial is a randomized, double-masked (neither participants nor researchers know who gets which treatment), controlled Phase II study. **You may be eligible if...** - You are aged 18–75 and have had Sjögren's syndrome for at least 3 months - You are only using artificial tears as your current dry eye treatment - Your dry eye symptoms are moderate to severe (Global SANDE score ≥ 40) - Your current systemic medications have been stable for at least one month **You may NOT be eligible if...** - You use prescription eye drops (other than artificial tears) for dry eye - You have recently changed your systemic medications - You are pregnant or breastfeeding - You have active eye infections or other significant eye conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant Human Proteoglycan 4

rhPRG4 450ug/ml

DRUGVehicle Control

PBS based Vehicle Conrtol


Locations(6)

Sydney Eye Hospital

Sydney, New South Wales, Australia

Univ of New South Wales

Sydney, New South Wales, Australia

OTA

Brisbane, Queensland, Australia

Queensland University of Technology

Brisbane, Queensland, Australia

University of the Sunshine Coast

Maroochydore, Queensland, Australia

University of Melbourne

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07118241


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