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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07118241




Registration number
NCT07118241
Ethics application status
Date submitted
5/08/2025
Date registered
12/08/2025
Date last updated
12/08/2025

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
RHPRG4-SJÖGREN'S-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjögren's Syndrome 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Recombinant Human Proteoglycan 4
Treatment: Drugs - Vehicle Control

Placebo comparator: Vehicle Control - PBS Based Vehicle Control

Experimental: rhPRG4 450ug/ml - rhPRG4 450ug/ml


Treatment: Drugs: Recombinant Human Proteoglycan 4
rhPRG4 450ug/ml

Treatment: Drugs: Vehicle Control
PBS based Vehicle Conrtol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From baseline to the end of treatment at day 28
Secondary outcome [1] 0 0
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events for the study duration
Timepoint [1] 0 0
From baseline to day 28
Secondary outcome [2] 0 0
To assess the safety of rhPRG4 by observation of the change in BCVA over 28 days
Timepoint [2] 0 0
From baseline to day 28
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
From baseline to day 28
Secondary outcome [4] 0 0
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
Timepoint [4] 0 0
From baseline to day 28
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
From baseline to day 28
Secondary outcome [6] 0 0
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle at Day 28
Timepoint [6] 0 0
From baseline to day 28
Secondary outcome [7] 0 0
To assess the efficacy of rhPRG4 using the Oxford staining score, both per eye and as a total score per subject compared to vehicle at Day 28
Timepoint [7] 0 0
From baseline to day 28

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Univ of New South Wales - Sydney
Recruitment hospital [3] 0 0
OTA - Brisbane
Recruitment hospital [4] 0 0
Queensland University of Technology - Brisbane
Recruitment hospital [5] 0 0
University of the Sunshine Coast - Maroochydore
Recruitment hospital [6] 0 0
University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lubris Bio Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marie Clinical Project Manager
Address 0 0
Country 0 0
Phone 0 0
+61 0403 318 910
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07118241