Sjogren's Syndrome With Dry EyePhase 1/2NCT06520202
RHPRG4 FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
A Phase 1/2 study testing rhPRG4 (450 µg/mL) in people with Sjogren's Syndrome With Dry Eye, run by Lubris Bio Pty Ltd at 1 site in Australia.
Trial summary
A 1-day, randomized (1:1) controlled, masked, pre-market study. Subjects with moderate to severe Sjögren's related Dry Eye Disease will be evaluated at 0, 5, 30 \& 90 minutes post dose of either rhPRG4 (Treatment group) or vehicle (Crossover group). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjogren's Syndrome With Dry Eye
- What is being tested?
- rhPRG4 (450 µg/mL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Nov 2024to 11 Nov 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18-75 years of age.
- Subjects previously diagnosed with Sjögren's Syndrome
- Subjects diagnosed with Sjögren's related Dry Eye Disease for at least 3 months (current use of artificial tears for the treatment of Dry Eye)
- VAS Eye Dryness (100-point scale) score ≥ 45 mm;
- Osmolarity ≥ 312 mOsm/L in the worst performing eye;
- 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 dry eye in either eye, including but not limited to significant conjunctivochalasis, SLK, limbal stem cell deficiency, allergic conjunctivitis, GPC, AKC, anterior basement membrane dystrophies, recurrent corneal erosion, neurotrophic keratitis, PCEDs, exposure keratitis and moderate to severe blepharitis;
- History of any ocular surgery (including laser or refractive surgical procedures) in either eye within 30 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;
- Presence or history of any ocular or systemic disorder or condition that might significantly hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trial procedures (e.g. ocular trauma, progressive or degenerative corneal conditions, uveitis, systemic infection), or initiation or cessation any systemic drug during the study period that is known to induce dry eye disease;
- Known hypersensitivity to one of the components of the study or procedural medications;
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- Participation in another clinical study at the same time as the present study or within 14 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
1 site in 1 country.
About this study
Official title: A PHASE II PROSPECTIVE RANDOMIZED CROSSOVER STUDY ASSESSING THE ACUTE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
A 1-day, randomized (1:1) controlled, masked, pre-market study. Subjects with moderate to severe Sjögren's related Dry Eye Disease will be evaluated at 0, 5, 30 \& 90 minutes post dose of either rhPRG4 (Treatment group) or vehicle (Crossover group). At 90 minutes, Crossover group subjects will be administered rhPRG4, then evaluated 5 \& 30 minutes after rhPRG4 instillation (95 \& 120 minutes from baseline). All subjects will self-report for the remainder of the day at 4 hours and 8 hours post dose.
- Conditions
- Sjogren's Syndrome With Dry Eye
- Being tested
- rhPRG4 (450 µg/mL), Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhPRG4 (450 µg/mL)Drug
1-2 drops of rhPRG4 450 µg/mL solution in both eyes
VehicleDrug
Sterile isotonic aqueous solution for ocular administration containing 0.01% polysorbate 20.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Drug: rhPRG4 (450 µg/mL) |
| Vehicle Group | Active comparator | Not described Receives: Drug: Vehicle |
| Crossover Group | Experimental | Not described Receives: Drug: rhPRG4 (450 µg/mL) |
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 90 minutes
Measured: 90 minutes
• To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events
Measured: 90 minutes
Secondary outcomes (6)
• To assess the efficacy of rhPRG4 using the average VAS score for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia and total VAS
Measured: at 5 minutes, 30 minutes, 90 minutes, 4 & 8 hours
• To assess the efficacy of rhPRG4 using the minimum inter-eye non-invasive tear film breakup time (TBUT): min(OU)
Measured: 30 minutes, 90 minutes
• To assess the efficacy of rhPRG4 using maximum inter-eye tear osmolarity: max(OU)
Measured: 30 minutes, 90 minutes
• To assess the efficacy of rhPRG4 using a patient questionnaire
Measured: 90 minutes
• To assess the safety of rhPRG4 by observation of the Best Corrected Visual Acuity (BCVA)
Measured: 90 minutes
• To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE)
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start5 Nov 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Why it stopped: Efficacy signal substantial enough to move to a larger sturdy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's Syndrome With Dry EyeStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
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
- NCT06520202
- Sponsor's protocol ID
- RHPRG4-SJÖGREN'S-001
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II PROSPECTIVE RANDOMIZED CROSSOVER STUDY ASSESSING THE ACUTE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
- ClinicalTrials.gov ID
- NCT06520202
- Acronym / sponsor ID
- RHPRG4-SJÖGREN'S-001
- Conditions
- Sjogren's Syndrome With Dry Eye
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficacy signal substantial enough to move to a larger sturdy
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lubris Bio Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 25 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.
A 1-day, randomized (1:1) controlled, masked, pre-market study. Subjects with moderate to severe Sjögren's related Dry Eye Disease will be evaluated at 0, 5, 30 \& 90 minutes post dose of either rhPRG4 (Treatment group) or vehicle (Crossover group). At 90 minutes, Crossover group subjects will be administered rhPRG4, then evaluated 5 \& 30 minutes after rhPRG4 instillation (95 \& 120 minutes from baseline). All subjects will self-report for the remainder of the day at 4 hours and 8 hours post dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: rhPRG4 (450 µg/mL) |
| Vehicle Group | Active comparator | Drug: Vehicle |
| Crossover Group | Experimental | Drug: rhPRG4 (450 µg/mL) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects 18-75 years of age.
- Subjects previously diagnosed with Sjögren's Syndrome
- Subjects diagnosed with Sjögren's related Dry Eye Disease for at least 3 months (current use of artificial tears for the treatment of Dry Eye)
- VAS Eye Dryness (100-point scale) score ≥ 45 mm;
- Osmolarity ≥ 312 mOsm/L in the worst performing eye;
Key exclusion criteria (14 listed)
- Evidence of an active ocular infection in either eye;
- History or presence of ocular surface disorders not related to dry eye in either eye, including but not limited to significant conjunctivochalasis, SLK, limbal stem cell deficiency, allergic conjunctivitis, GPC, AKC, anterior basement membrane dystrophies, recurrent corneal erosion, neurotrophic keratitis, PCEDs, exposure keratitis and moderate to severe blepharitis;
- History of any ocular surgery (including laser or refractive surgical procedures) in either eye within 30 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;
- Presence or history of any ocular or systemic disorder or condition that might significantly hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trial procedures (e.g. ocular trauma, progressive or degenerative corneal conditions, uveitis, systemic infection), or initiation or cessation any systemic drug during the study period that is known to induce dry eye disease;
- Known hypersensitivity to one of the components of the study or procedural medications;
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 (450 µg/mL)1-2 drops of rhPRG4 450 µg/mL solution in both eyes | Drug | Crossover Group, Treatment Group |
| VehicleSterile isotonic aqueous solution for ocular administration containing 0.01% polysorbate 20. | Drug | Vehicle Group |
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 90 minutes
Time frame: 90 minutes
• To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events
Time frame: 90 minutes
6 secondary outcomes
• To assess the efficacy of rhPRG4 using the average VAS score for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia and total VAS
Time frame: at 5 minutes, 30 minutes, 90 minutes, 4 & 8 hours
• To assess the efficacy of rhPRG4 using the minimum inter-eye non-invasive tear film breakup time (TBUT): min(OU)
Time frame: 30 minutes, 90 minutes
• To assess the efficacy of rhPRG4 using maximum inter-eye tear osmolarity: max(OU)
Time frame: 30 minutes, 90 minutes
• To assess the efficacy of rhPRG4 using a patient questionnaire
Time frame: 90 minutes
• To assess the safety of rhPRG4 by observation of the Best Corrected Visual Acuity (BCVA)
Time frame: 90 minutes
• To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE)
Time frame: 90 minutes
Results and safety
The study was stopped early (reason given: Efficacy signal substantial enough to move to a larger sturdy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (450 µg/mL) in people with Sjogren's Syndrome With Dry Eye, run by Lubris Bio Pty Ltd at 1 site 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 6 inclusion and 14 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 move to a larger sturdy). 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 90 minutes (time frame: 90 minutes). 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 29 Sep 2025.