rhPRG4 (450 µg/mL) eye drops for Sjögren's-related dry eye

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

This study will test whether rhPRG4 eye drops relieve symptoms and improve corneal staining in adults with Sjögren's-related dry eye compared with a placebo eye drop.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Lubris Bio Pty Ltd (Industry-sponsored)
• Locations: 6 sites (Sydney, New South Wales and 5 other locations)
• Trial ID: NCT07118241 on ClinicalTrials.gov

What this trial studies

This is a Phase II, prospective, randomized, double-masked, multi-center trial in Australia comparing topical recombinant human proteoglycan 4 (rhPRG4 450 µg/mL) to a matching vehicle control. Adults aged 18–75 with a confirmed Sjögren's diagnosis for at least three months and defined symptom and corneal staining thresholds are eligible. Participants must be using only artificial tears topically and on stable systemic medications before enrollment. Primary outcomes focus on safety and measures of ocular symptoms (Global SANDE, VAS) and corneal fluorescein staining.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with Sjögren's for at least three months, moderate-to-severe dry eye symptoms (Global SANDE ≥ 40 and VAS average ≥ 25 mm) and Oxford corneal staining grade 1–2 in both eyes who use only artificial tears.

Not a fit: Patients with very mild or very severe corneal disease outside the Oxford 1–2 range, those using other topical treatments, or those unable to meet the symptom score requirements are unlikely to match the trial population and may not benefit.

Why it matters

Potential benefit: If successful, rhPRG4 eye drops could reduce dry eye symptoms and improve corneal surface health in people with Sjögren's-related dry eye.

How similar studies have performed: Preclinical and early-phase work on lubricating proteins like PRG4 suggests potential benefit for ocular surface disease, but randomized data in Sjögren's patients remain limited.

Eligibility criteria

Inclusion Criteria:

1. Have the ability to comprehend and provide a signed and dated consent form.
2. Are 18-75 years at time of consent;
3. Have been diagnosed with SS for at least 3 months prior to ICF;
4. Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;
5. Have been stably using systemic medications for at least one month prior to Visit 1;
6. Have Global SANDE score ≥ 40;
7. Average VAS score for typical symptoms of dry eye (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none \< 5 mm;
8. Have Oxford corneal fluorescein staining grade of ≥ 1 and ≤ 2 in each eye (OD \& OS both ≥ 1 and ≤ 2);
9. Stated willingness to comply with all study procedures, attend all scheduled clinic visits, and continue participation for the duration of the study.
10. Ability to self-administer study medication and willingness to adhere to the medication regimen.

Exclusion Criteria

1. Are currently or have a history of any ocular or systemic disorder or condition other than dry eye that based on investigator judgment will interfere with the interpretation of the study results. Examples of ocular or systemic disorders or conditions include active ocular infection, conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis, moderate to severe blepharitis, ocular trauma, progressive or degenerative corneal conditions, uveitis, and systemic infection;
2. Have used any topical ocular medications (other than artificial tears), therapeutic medical devices, or undergone ocular surgery within the 30 days prior to Visit 1. Topical ocular medications include cyclosporine, lifitegrast, corticosteroid eye drops, and autologous/serum. Therapeutic medical devices include trigeminal stimulation, meibomian glad warming (excepting at home masks) or expression, intense pulsed light, low level light therapy, etc. Ocular surgeries include laser or refractive surgical procedures, insertion of punctal or punctal cauterization;
3. Are unwilling to forgo the use of topical medications (other than IMP and limited artificial tear use), medical devices or ocular surgery from Visit 1 through Visit 4.
4. Have only one eye;
5. Are unwilling to adhere to t.i.d. administration of vehicle during run-in;
6. Are unwilling to limit the use of artificial tears to no more than 4 days during run-in;
7. Have begun regularly using systemic compounds for SS or SS-related dry eye during the one month prior to Visit 1. Systemic compounds include omega-3 oil (fish oil, flaxseed oil, etc.), systemic corticosteroids, immunosuppressants, and biologics that based on investigator judgment will interfere with the interpretation of the study results.
8. Are unwilling to maintain a stable regimen of systemic compound use during the duration of the study;
9. Have known hypersensitivity to one of the components of the study or procedural medications;
10. Have participated in another clinical study at the same time as the present study or within 30 days of Visit 1;
11. Have a history of drug, medication or alcohol abuse or addiction;
12. Are females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) who meet any one of the following conditions:

    1. are currently pregnant or,
    2. have a positive result on the urine pregnancy test at the Screening Visit or,
    3. intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,
    4. are breast-feeding or,
    5. not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods, during the entire course of and 30 days after the study treatment periods;
13. Are males with a female partner of child bearing potential where:

    1. the male is not surgically sterilized or,
    2. where the male partner cannot provide information regarding the female partner's child bearing status or,
    3. where the child bearing status of the female partner does not meet that of Exclusion Criteria 12; however, the female partner of a male participant will not be required meet Exclusion Criteria 12b.
14. Have a history of a serious physical or psychiatric disorder that, in the investigator's opinion, could prevent compliance with study procedures or affect study participation;
15. Have any other surgical or medical condition or finding that in the opinion of the investigator would compromise the subject's safety or participation in the study.

Where this trial is running

Sydney, New South Wales and 5 other locations

• Sydney Eye Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
• Univ of New South Wales — Sydney, New South Wales, Australia (Recruiting)
• Ota — Brisbane, Queensland, Australia (Recruiting)
• Queensland University of Technology — Brisbane, Queensland, Australia (Recruiting)
• University of the Sunshine Coast — Maroochydore, Queensland, Australia (Recruiting)
• University of Melbourne — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Edward CEO

Conditions Sjögren's Syndrome; Sjogrens Syndrome; Dry Eye