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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07118254




Registration number
NCT07118254
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 CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Scientific title
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Secondary ID [1] 0 0
RHPRG4-oGVHD-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular Graft Versus Host Disease 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - rhPRG4 450ug/ml
Treatment: Drugs - Vehicle Control

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

Placebo comparator: Vehicle Control - PBS Based Vehicle Control


Treatment: Drugs: rhPRG4 450ug/ml
Treatment

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

Outcomes
Primary outcome [1] 0 0
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment
Timepoint [1] 0 0
Baseline to day 28
Primary outcome [2] 0 0
To assess the efficacy of rhPRG4 using the total VAS score (sum of dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia, anchors: none & severe) compared to vehicle after 28 days of treatment
Timepoint [2] 0 0
From baseline to day 28
Secondary outcome [1] 0 0
To assess the efficacy of rhPRG4 using individual VAS scores for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none & severe) compared to vehicle after 28 days of treatment
Timepoint [1] 0 0
From baseline to day 28
Secondary outcome [2] 0 0
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle after 28 days of treatment
Timepoint [2] 0 0
From baseline to day 28
Secondary outcome [3] 0 0
To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU) compared to vehicle after 28 days of treatment
Timepoint [3] 0 0
From baseline to day 28
Secondary outcome [4] 0 0
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events over the study duration
Timepoint [4] 0 0
From baseline to day 28
Secondary outcome [5] 0 0
To assess the safety of rhPRG4 by observation of the Best Corrected Distance Visual Acuity (BCVA)
Timepoint [5] 0 0
From baseline to day 28
Secondary outcome [6] 0 0
To assess the safety of rhPRG4 by observation of signs evaluated by safety examination (ophthalmic examination plus slit lamp examination (SLE) of meibomian glands, eyelid Erythema, eyelid oedema, lashes, conjunctival erythema, lens, iris, anterior chamb
Timepoint [6] 0 0
From baseline to day 28
Secondary outcome [7] 0 0
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
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 18-80 years of age at time of consent;
3. Have been diagnosed with oGVHD for at least 3 months prior to giving informed consent to participate in the trial;
4. Current use of artificial tears for the treatment of oGVHD related dry eye;
5. Have been stably using systemic medications for at least 14 days prior to Visit 1;
6. VAS Eye Dryness (100-point scale) score = 40 mm;
7. Average VAS score for all 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 = 2 using the Oxford scale in the worst performing eye
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
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. History of any ocular surgery (including laser or refractive surgical procedures) or therapeutic medical devices in either eye within 30 days before study enrollment. 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; Ocular surgery will not be allowed during study participation; 3. Initiation of new therapeutic modalities within 14 days of Visit 1; 4. Have a known hypersensitivity to one of the components of the study or procedural medications; 5. Have participated in another clinical study at the same time as the present study or within 30 days of the Visit 1; 6. Have a history of drug, medication or alcohol abuse or addiction; 7. 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/Baseline 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; 8. Per the discretion of the investigator or designee, history of a serious physical or mental disorder that prevents the subject from attending study visits, complying with study-related procedures, and/or prevents the subject's ability to make decisions on their own; 9. 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
Crossover
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
15
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
OTA - Brisbane
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 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/NCT07118254