RHPRG4 FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE

September 24, 2025 updated by: Lubris Bio Pty Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia
        • Sydney Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects 18-75 years of age.
  2. Subjects previously diagnosed with Sjögren's Syndrome
  3. 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)
  4. VAS Eye Dryness (100-point scale) score ≥ 45 mm;
  5. Osmolarity ≥ 312 mOsm/L in the worst performing eye;
  6. Only subjects who satisfy all Informed Consent requirements may be included in the study.

Exclusion Criteria:

Diagnosis and Main Criteria for Exclusion:

  1. Evidence of an active ocular infection in either eye;
  2. 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;
  3. 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;
  4. 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;
  5. Known hypersensitivity to one of the components of the study or procedural medications;
  6. Participation in another clinical study at the same time as the present study or within 14 days of screening/baseline visit;
  7. History of drug, medication or alcohol abuse or addiction;
  8. 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:
  9. are currently pregnant or,
  10. have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
  11. intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,
  12. are breast-feeding or,
  13. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
Drug: rhPRG4 (450 µg/mL)
1-2 drops of rhPRG4 450 µg/mL solution in both eyes
Active Comparator: Vehicle Group
Drug: Vehicle
Sterile isotonic aqueous solution for ocular administration containing 0.01% polysorbate 20.
Experimental: Crossover Group
Drug: rhPRG4 (450 µg/mL)
1-2 drops of rhPRG4 450 µg/mL solution in both eyes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
• 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
90 minutes
• To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events
Time Frame: 90 minutes
90 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
• 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
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
30 minutes, 90 minutes
• To assess the efficacy of rhPRG4 using maximum inter-eye tear osmolarity: max(OU)
Time Frame: 30 minutes, 90 minutes
30 minutes, 90 minutes
• To assess the efficacy of rhPRG4 using a patient questionnaire
Time Frame: 90 minutes
90 minutes
• To assess the safety of rhPRG4 by observation of the Best Corrected Visual Acuity (BCVA)
Time Frame: 90 minutes
90 minutes
• To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE)
Time Frame: 90 minutes
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lubris Bio Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RHPRG4-SJÖGREN'S-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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