Ocular Lubricants for Dry Eye Syndrome

(SPHINX Trial)

This trial compares two types of lubricating eye drops to determine which one more effectively eases symptoms of dry eye syndrome, such as dryness and discomfort. Participants will use one eye drop twice a day and the other four times a day, each for four weeks, with a break in between. The study aims to determine if the less frequent drop is equally effective. It is ideal for individuals with dry eye symptoms who are willing to stop using their usual artificial tears during the study. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how they can benefit more patients.

You will need to stop using any artificial tear supplements and only use the study drops during the trial. If you are on systemic medications that can cause dry eye, you must have been on a stable dose for at least 30 days before the trial and cannot change the dose during the study.

Research has shown that both Systane Pro PF and Thealoz Duo are generally well-tolerated by users. Studies have found Systane Pro PF to be safe, with only mild side effects such as slight eye irritation or redness in some cases. Importantly, no major harmful effects have been reported for this product.

Thealoz Duo has also undergone thorough study, with no harmful effects reported. Patients have generally found it effective and safe, with many preferring it over other eye drops.

Researchers are excited about these treatments because they offer new approaches to managing Dry Eye Syndrome. Unlike standard lubricants like Refresh Tears or Blink, Systane Pro PF and Thealoz Duo are being evaluated for their sequential use, which could enhance their effectiveness. Systane Pro PF is preservative-free, minimizing irritation for sensitive eyes, while Thealoz Duo contains trehalose, a sugar known for protecting and hydrating the ocular surface. This combination might offer longer-lasting relief and better protection compared to existing options.

This trial will compare the effectiveness of two ocular lubricants, Systane Pro PF and Thealoz Duo, in treating dry eye syndrome. Research has shown that Systane Pro PF reduces dry eye symptoms, with users noticing significant improvement after a month. Thealoz Duo also shows promise, as studies have demonstrated its ability to improve dry eye symptoms and increase user satisfaction. Its formula, which includes trehalose and hyaluronic acid, protects and hydrates the eye surface. Participants will use Systane Pro PF for four weeks followed by Thealoz Duo for another four weeks, or vice versa, to evaluate each treatment's effectiveness. Both treatments effectively relieve dry eye symptoms, but results can vary based on individual needs.¹⁶⁷⁸⁹