Phase II Study of Recombinant Human Proteoglycan 4 Eye Drops for Treating Sjgrens Syndrome Related Dry Eye Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a topical treatment called recombinant human proteoglycan 4 rhPRG4 for people with Sjgrens Syndrome who have dry eye disease. This Phase II, multi-center, randomized, double-masked controlled study is conducted in Australia to compare rhPRG4 to a placebo vehicle. The study aims to help improve symptoms and signs of dry eye related to Sjgrens Syndrome. Participants are randomly assigned to receive either rhPRG4 at a concentration of 450 gml or a PBS-based vehicle control. The treatment is applied topically to the eyes. The study lasts for 28 days, during which participants use the assigned treatment following the prescribed regimen. The trial includes regular assessments to monitor safety and efficacy throughout this period. During the study, participants attend scheduled visits where researchers evaluate eye health using corneal staining tests, symptom questionnaires including the SANDE score and visual analogue scales for dryness and discomfort, and eye examinations such as slit lamp evaluations and intraocular pressure measurements. Safety is monitored by observing any adverse events and changes in vision. The main outcome is the frequency of patients achieving complete resolution of corneal staining by day 28. Participants are asked to adhere to the treatment schedule and attend all visits during the trial duration.

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