Ocular Graft Versus Host DiseasePhase 2NCT07118254
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)
A Phase 2 study testing rhPRG4 450ug/ml in people with Ocular Graft Versus Host Disease, run by Lubris Bio Pty Ltd at 3 sites in Australia.
Trial summary
An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ocular Graft Versus Host Disease
- What is being tested?
- rhPRG4 450ug/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 3 sitesAustralia
- Study dates
- 17 Sep 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the ability to comprehend and provide a signed and dated consent form.
- Are 18-80 years of age at time of consent;
- Have been diagnosed with oGVHD for at least 3 months prior to giving informed consent to participate in the trial;
- Current use of artificial tears for the treatment of oGVHD related dry eye;
- Have been stably using systemic medications for at least 14 days prior to Visit 1;
- VAS Eye Dryness (100-point scale) score ≥ 40 mm;
Show all 10Show fewer
- 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;
- Have Oxford corneal fluorescein staining grade of ≥ 2 using the Oxford scale in the worst performing eye
- 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.
Who cannot join
- 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:
- 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; 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
OTA
Brisbane, Queensland
Mark Hinds, 61 7 3608 2074
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria
Sophie Gutknecht, + 61 3 9342 2641, Eyetrials@mh.org.au
Elaine Chong, MD, +61 413 668 695, Eyetrials@mh.org.au
- Not yet recruiting
Sydney Eye Hospital
Sydney, New South Wales
Stephanie Watson, +61 02 9385 6551, stephanie.watson@sydney.edu.au
About this study
An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period.
- Conditions
- Ocular Graft Versus Host Disease
- Being tested
- rhPRG4 450ug/ml, Vehicle Control
- Keywords
- oGVHD, Dry Eye, Graft Versus Host Disease
- Medical subject headings
- Dry Eye Syndromes, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhPRG4 450ug/mlDrug
Treatment
Vehicle ControlDrug
PBS Based Vehicle Control
| Study group | Role | What they receive |
|---|---|---|
| rhPRG4 450ug/ml | Experimental | rhPRG4 450ug/ml Receives: Drug: rhPRG4 450ug/ml |
| Vehicle Control | Placebo comparator | PBS Based Vehicle Control Receives: Drug: Vehicle Control |
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 total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment
Measured: Baseline to day 28
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
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
Measured: From baseline to day 28
Secondary outcomes (7)
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
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
Measured: From baseline to day 28
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle after 28 days of treatment
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle after 28 days of treatment
Measured: From baseline to day 28
To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU) compared to vehicle after 28 days of treatment
To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU) compared to vehicle after 28 days of treatment
Measured: From baseline to day 28
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events over the study duration
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events over the study duration
Measured: From baseline to day 28
To assess the safety of rhPRG4 by observation of the Best Corrected Distance Visual Acuity (BCVA)
To assess the safety of rhPRG4 by observation of the Best Corrected Distance Visual Acuity (BCVA)
Measured: From baseline to day 28
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
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 chamber, hyperemia, corneal transparency \& corneal neovascularization)
Measured: From baseline to day 28
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
Measured: From baseline to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start17 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lubris Bio Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118254
- Sponsor's protocol ID
- RHPRG4-oGVHD-002
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07118254
- Acronym / sponsor ID
- RHPRG4-oGVHD-002
- Conditions
- Ocular Graft Versus Host Disease
- Keywords
- oGVHD, Dry Eye, Graft Versus Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Lubris Bio Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Aug 2025 (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.
An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhPRG4 450ug/ml | Experimental | Drug: rhPRG4 450ug/mlrhPRG4 450ug/ml |
| Vehicle Control | Placebo comparator | Drug: Vehicle ControlPBS Based Vehicle Control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have the ability to comprehend and provide a signed and dated consent form.
- Are 18-80 years of age at time of consent;
- Have been diagnosed with oGVHD for at least 3 months prior to giving informed consent to participate in the trial;
- Current use of artificial tears for the treatment of oGVHD related dry eye;
- Have been stably using systemic medications for at least 14 days prior to Visit 1;
Key exclusion criteria (6 listed)
- 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:
- 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,
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 |
|---|---|---|
| rhPRG4 450ug/mlTreatment | Drug | rhPRG4 450ug/ml |
| Vehicle ControlPBS Based Vehicle Control | Drug | Vehicle Control |
Primary outcome
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment
Time frame: Baseline to day 28
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment
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
Time frame: From baseline to day 28
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
7 secondary outcomes
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
Time frame: From baseline to day 28
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle after 28 days of treatment
Time frame: From baseline to day 28
To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU) compared to vehicle after 28 days of treatment
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events over the study duration
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of the Best Corrected Distance Visual Acuity (BCVA)
Time frame: From baseline to day 28
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
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
Time frame: From baseline to day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhPRG4 450ug/ml in people with Ocular Graft Versus Host Disease, run by Lubris Bio Pty Ltd at 3 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward CEO (6193394016, etruitt@lubris.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment (time frame: Baseline to day 28). The study lists 2 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 26 Oct 2026.