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
NCT ID: NCT07118241
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-09-17
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle Control
PBS Based Vehicle Control
Vehicle Control
PBS based Vehicle Conrtol
rhPRG4 450ug/ml
rhPRG4 450ug/ml
Recombinant Human Proteoglycan 4
rhPRG4 450ug/ml
Interventions
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Recombinant Human Proteoglycan 4
rhPRG4 450ug/ml
Vehicle Control
PBS based Vehicle Conrtol
Eligibility Criteria
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Inclusion Criteria
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
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,
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.
18 Years
75 Years
ALL
No
Sponsors
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Lubris Bio Pty Ltd
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RHPRG4-SJÖGREN'S-002
Identifier Type: -
Identifier Source: org_study_id
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