Ocular Graft-versus-host DiseasePhase 1/2NCT06495307
RHPRG4 FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
A Phase 1/2 study testing rhPRG4 in people with Ocular Graft-versus-host Disease, run by Lubris Bio Pty Ltd at 2 sites in Australia.
Trial summary
rhPRG4-GVHD-001 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with moderate to severe dry eye secondary to chronic GVHD. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ocular Graft-versus-host Disease
- What is being tested?
- rhPRG4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesAustralia
- Study dates
- 14 Feb 2025to 22 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis and Main Criteria for Inclusion:
- All to be queried and checked at the screening visit (V1):
- Subjects 18 years of age or older;
- Subjects diagnosed with oGVHD for at least 3 months (current use of artificial tears for the treatment of GVHD);
- VAS Eye Dryness (100-point scale) score ≥ 60 mm;
- Tear Osmolarity ≥ 312 in either eye;
- Corneal staining score with fluorescein ≥ 2 using the Oxford scale in the worst performing eye; staining must include quadrants beyond only inferior or superior staining;
- Only subjects who satisfy all Informed Consent requirements may be included in the study.
Who cannot join
- Diagnosis and Main Criteria for Exclusion:
- Evidence of an active ocular infection in either eye;
- History or presence of ocular surface disorders not related to oGVHD in either eye, including but not limited to significant 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 and moderate to severe blepharitis;
- History of any ocular surgery (including laser or refractive surgical procedures) in either eye within 90 days before study enrollment. Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period;
- Initiation of new therapeutic modalities within 30 days of recruitment;
- Artificial rescue tears are allowed as long as they are recorded in a diary;
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- Known hypersensitivity to one of the components of the study or procedural medications;
- Participation in another clinical study at the same time as the present study or within 60 days of screening/baseline visit;
- History of drug, medication or alcohol abuse or addiction;
- Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
- are currently pregnant or,
- have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
- intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,
- are breast-feeding or,
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
OTA
Brisbane, Queensland
Sydney Eye Hospital
Sydney, New South Wales
About this study
Official title: A PHASE I PROSPECTIVE OPEN LABEL STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
rhPRG4-GVHD-001 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with moderate to severe dry eye secondary to chronic GVHD.
- Conditions
- Ocular Graft-versus-host Disease
- Being tested
- rhPRG4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhPRG4Drug
Sterile isotonic aqueous solution containing rhPRG4 (450 µg/mL) for topical administration, 10 mM sodium phosphate, 150 mM sodium chloride \& 0.01% polysorbate 20 at pH 7.2. In all subjects, both eyes will be treated
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: rhPRG4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of rhPRG4 using the average VAS score assessing subjects' eye dryness (Question: Rate the dryness of your eye; anchors: 0 = no discomfort, 100 = maximal discomfort) at Day 28
Measured: 28
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) at Day 28
Measured: 28
To assess the safety of rhPRG4 by observation of the frequency and severity of treatment-emergent adverse events
Measured: 28
Secondary outcomes (9)
To assess the efficacy of rhPRG4 using the average VAS score for foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia and total VAS (anchors: not at all & very)
Measured: 28
To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU)
Measured: 28
To assess the efficacy of rhPRG4 using the absolute difference in inter-eye tear film breakup time (TBUT): min(OU)osmolarity: abs(OD - OS)
Measured: 28
To assess the efficacy of rhPRG4 using the number of instillations of rescue artificial tear per day
Measured: 28
To assess the efficacy of rhPRG4 using a patient questionnaire
Measured: 28
To assess the efficacy of rhPRG4 by NIH Eye Score
Measured: 28
To assess the safety of rhPRG4 by observation of the Best Corrected Visual Acuity (BCVA)
Measured: 28
To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp (SLE)
Measured: 28
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
Measured: 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start14 Feb 2025
- Primary completion22 Mar 2025
- Study completion22 Mar 2025
Why it stopped: Efficacy signal substantial enough to more to larger study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lubris Bio Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lubris, LLC, Sydney Eye Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495307
- Sponsor's protocol ID
- RHPRG4-OGVHD-001
- Status last verified
- Jan 2026
- First submitted
- 2 Jul 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I PROSPECTIVE OPEN LABEL STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
- ClinicalTrials.gov ID
- NCT06495307
- Acronym / sponsor ID
- RHPRG4-OGVHD-001
- Conditions
- Ocular Graft-versus-host Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficacy signal substantial enough to more to larger study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Lubris Bio Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Lubris, LLC, Sydney Eye Hospital
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 22 Mar 2025 (actual)
- Study completion
- 22 Mar 2025 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
rhPRG4-GVHD-001 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with moderate to severe dry eye secondary to chronic GVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: rhPRG4 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects 18 years of age or older;
- Subjects diagnosed with oGVHD for at least 3 months (current use of artificial tears for the treatment of GVHD);
- VAS Eye Dryness (100-point scale) score ≥ 60 mm;
- Tear Osmolarity ≥ 312 in either eye;
- Corneal staining score with fluorescein ≥ 2 using the Oxford scale in the worst performing eye; staining must include quadrants beyond only inferior or superior staining;
Key exclusion criteria (15 listed)
- Evidence of an active ocular infection in either eye;
- History or presence of ocular surface disorders not related to oGVHD in either eye, including but not limited to significant 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 and moderate to severe blepharitis;
- History of any ocular surgery (including laser or refractive surgical procedures) in either eye within 90 days before study enrollment. Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period;
- Initiation of new therapeutic modalities within 30 days of recruitment;
- Artificial rescue tears are allowed as long as they are recorded in a diary;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhPRG4Sterile isotonic aqueous solution containing rhPRG4 (450 µg/mL) for topical administration, 10 mM sodium phosphate, 150 mM sodium chloride \& 0.01% polysorbate 20 at pH 7.2. In all subjects, both eyes will be treated | Drug | Treatment |
Primary outcome
To assess the efficacy of rhPRG4 using the average VAS score assessing subjects' eye dryness (Question: Rate the dryness of your eye; anchors: 0 = no discomfort, 100 = maximal discomfort) at Day 28
Time frame: 28
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) at Day 28
Time frame: 28
To assess the safety of rhPRG4 by observation of the frequency and severity of treatment-emergent adverse events
Time frame: 28
9 secondary outcomes
To assess the efficacy of rhPRG4 using the average VAS score for foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia and total VAS (anchors: not at all & very)
Time frame: 28
To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU)
Time frame: 28
To assess the efficacy of rhPRG4 using the absolute difference in inter-eye tear film breakup time (TBUT): min(OU)osmolarity: abs(OD - OS)
Time frame: 28
To assess the efficacy of rhPRG4 using the number of instillations of rescue artificial tear per day
Time frame: 28
To assess the efficacy of rhPRG4 using a patient questionnaire
Time frame: 28
To assess the efficacy of rhPRG4 by NIH Eye Score
Time frame: 28
To assess the safety of rhPRG4 by observation of the Best Corrected Visual Acuity (BCVA)
Time frame: 28
To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp (SLE)
Time frame: 28
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
Time frame: 28
Results and safety
The study was stopped early (reason given: Efficacy signal substantial enough to more to larger study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing rhPRG4 in people with Ocular Graft-versus-host Disease, run by Lubris Bio Pty Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Efficacy signal substantial enough to more to larger study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of rhPRG4 using the average VAS score assessing subjects' eye dryness (Question: Rate the dryness of your eye; anchors: 0 = no discomfort, 100 = maximal discomfort) at Day 28 (time frame: 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.