Recruiting

Testing a new eye drop treatment for Sjögren's-related dry eye

Plain-English translation of NCT07118241 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This study is testing a new eye drop called rhPRG4 to see if it can help people with Sjögren's syndrome who suffer from dry eye disease. Sjögren's is an autoimmune condition that damages the glands that make tears, leading to painful, dry eyes. Researchers want to find out whether this medication works better than a placebo to reduce symptoms and improve eye comfort.

Many people with Sjögren's syndrome have severe dry eye that doesn't respond well to artificial tears alone. This trial exists to see whether this new treatment could offer better relief and help protect the surface of the eye from the damage caused by chronic dryness.

Do you qualify?

You likely qualify if…

you have been diagnosed with Sjögren's syndrome for at least 3 months
you are between 18 and 75 years old
you have been using only artificial tears to treat your dry eye for at least 30 days before starting the study
you have moderate to severe dry eye symptoms (including dryness, grittiness, burning, or blurred vision) that are affecting your daily life
you are willing and able to use the study medication three times a day and attend all study visits

You likely don't qualify if…

you have an active eye infection or other eye condition (such as allergic conjunctivitis or severe inflammation) besides dry eye
you have used other prescription eye drops (like cyclosporine or steroid drops) or had eye procedures within the past 30 days
you have only one eye
you have recently started new systemic medications for Sjögren's syndrome (such as fish oil supplements, oral steroids, or biologic drugs) in the past month
you are unwilling to limit artificial tear use to no more than 4 times per day during the study run-in period

What participation looks like

If you join this study, you'll be randomly assigned to receive either the new eye drop (rhPRG4) or a placebo (dummy drop) three times a day. You'll visit the clinic several times to have your eyes examined, answer questions about your symptoms, and let the researchers check how well the treatment is working. The study takes place in Australia and involves careful monitoring of your eye health and comfort over the course of the trial.

AI-generated summary from trial data · Jun 22, 2026 · Not medical advice

Trial locations(6 sites)

Australia

Sydney Eye Hospital, Sydney, New South Wales

Univ of New South Wales, Sydney, New South Wales

OTA, Brisbane, Queensland

Queensland University of Technology, Brisbane, Queensland

University of the Sunshine Coast, Maroochydore, Queensland