What is rhPRG4 studying for Sjögren's related Dry Eye Disease?

RhPRG4 is being studied to evaluate its safety and effectiveness in treating dry eye symptoms caused by Sjögren's Syndrome. Researchers want to see if this topical eye treatment can improve corneal healing and reduce symptoms like dryness and irritation. The trial is sponsored by Lubris Bio Pty Ltd to better understand this potential therapy.

Who may be eligible for this Sjögren's Syndrome clinical trial?

Adults aged 18 to 75 years with a diagnosis of Sjögren's Syndrome for at least three months may be eligible. Participants should be using only artificial tears for dry eye and able to follow study procedures. Both men and women can join if they meet these and other health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this Sjögren's Syndrome clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should consider these potential costs when deciding to join.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID07118241

A Phase II Randomized, Double-Masked Study Comparing rhPRG4 450 gml Recombinant Human Proteoglycan 4 to Vehicle for Treating Sjf6grens Related Dry Eye Disease

Led by Lubris Bio Pty Ltd · Updated on 2026-02-05

Participants Needed

Research Sites

N/A

Total Duration

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 Sjgrens 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 Sjgrens 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

Age: 18Years - 75Years

All Genders

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

Research Team

Edward CEO

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