MedTrace Logo

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

NCT06520202 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-09-29

No results posted yet for this study

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). 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

Interventions

DRUG

rhPRG4 (450 µg/mL)

1-2 drops of rhPRG4 450 µg/mL solution in both eyes

DRUG

Vehicle

Sterile isotonic aqueous solution for ocular administration containing 0.01% polysorbate 20.

Sponsors & Collaborators

  • Lubris Bio Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2024-11-11
Completion
2024-11-11
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06520202 on ClinicalTrials.gov