A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 17, 2025

Primary Completion Date

July 30, 2026

Study Completion Date

August 31, 2026

Conditions
Sjögren's Syndrome
Interventions
DRUG

Recombinant Human Proteoglycan 4

rhPRG4 450ug/ml

DRUG

Vehicle Control

PBS based Vehicle Conrtol

Trial Locations (6)

Unknown

NOT_YET_RECRUITING

Sydney Eye Hospital, Sydney

NOT_YET_RECRUITING

Univ of New South Wales, Sydney

RECRUITING

OTA, Brisbane

NOT_YET_RECRUITING

Queensland University of Technology, Brisbane

NOT_YET_RECRUITING

University of the Sunshine Coast, Maroochydore

NOT_YET_RECRUITING

University of Melbourne, Melbourne

All Listed Sponsors
lead

Lubris Bio Pty Ltd

INDUSTRY

NCT07118241 - A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE | Biotech Hunter | Biotech Hunter