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

NCT07118241 | Recruiting Phase 2 DMC

• 1 other identifier: RHPRG4-SJÖGREN'S-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Sjögren's Syndrome

Keywords

Sjogrens Syndrome; Dry Eye

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28

  To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28

  From baseline to the end of treatment at day 28

Secondary Outcomes (7)

• To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events for the study duration

  From baseline to day 28

• To assess the safety of rhPRG4 by observation of the change in BCVA over 28 days

  From baseline to day 28

• To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE) (Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Hyperemia, Corneal transparency & Corneal neo

  From baseline to day 28

• To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)

  From baseline to day 28

• To assess the efficacy of rhPRG4 using the total VAS score for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none & severe) at Day 28

  From baseline to day 28

Study Arms (2)

Vehicle Control

PLACEBO COMPARATOR

PBS Based Vehicle Control

Drug: Vehicle Control

rhPRG4 450ug/ml

EXPERIMENTAL

rhPRG4 450ug/ml

Drug: Recombinant Human Proteoglycan 4

Interventions

Recombinant Human Proteoglycan 4 DRUG

rhPRG4 450ug/ml

rhPRG4 450ug/ml

Vehicle Control DRUG

PBS based Vehicle Conrtol

Vehicle Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have the ability to comprehend and provide a signed and dated consent form.
• Are 18-75 years at time of consent;
• Have been diagnosed with SS for at least 3 months prior to ICF;
• Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;
• Have been stably using systemic medications for at least one month prior to Visit 1;
• Have Global SANDE score ≥ 40;
• 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;
• Have Oxford corneal fluorescein staining grade of ≥ 1 and ≤ 2 in each eye (OD \& OS both ≥ 1 and ≤ 2);
• Stated willingness to comply with all study procedures, attend all scheduled clinic visits, and continue participation for the duration of the study.
• Ability to self-administer study medication and willingness to adhere to the medication regimen.

You may not qualify if:

• 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;
• 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;
• 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.
• Have only one eye;
• Are unwilling to adhere to t.i.d. administration of vehicle during run-in;
• Are unwilling to limit the use of artificial tears to no more than 4 days during run-in;
• 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.
• Are unwilling to maintain a stable regimen of systemic compound use during the duration of the study;
• Have known hypersensitivity to one of the components of the study or procedural medications;
• Have participated in another clinical study at the same time as the present study or within 30 days of Visit 1;
• Have a history of drug, medication or alcohol abuse or addiction;
• 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:
• are currently pregnant or,
• have a positive result on the urine pregnancy test at the Screening Visit or,
• intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,

Sponsors & Collaborators

• Lubris Bio Pty Ltd: lead

Study Sites (6)

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

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Edward CEO

CONTACT

6193394016; ertruitt@lubris.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

AU (6)