Autologous Serum Tears With Hyaluronate for Dry Eye Syndrome

This trial tests whether adding sodium hyaluronate, a moisturizing ingredient, to autologous serum eye drops (made from a patient's own blood) can more effectively treat moderate-to-severe dry eye disease. Participants will use one version of the drops in one eye and the standard version in the other to compare effectiveness. The goal is to determine if the new formula provides more relief and comfort. Individuals with moderate-to-severe dry eye symptoms for at least six months, including those with conditions like Sjögren's syndrome or Stevens-Johnson syndrome, might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research has shown that eye drops made from a patient's own blood, known as autologous serum eye drops (ASEDs), are generally safe for treating dry eye syndrome. Studies have found that these drops help maintain eye moisture and aid in healing the eye's surface. For individuals with moderate-to-severe dry eye, these drops have proven effective and well-tolerated over several months. While specific side effects are not detailed, regular use of ASEDs has improved symptoms and overall eye health in many studies. This suggests that adding sodium hyaluronate to these eye drops should not significantly alter their safety.¹²³⁴⁵

Unlike standard treatments for dry eye syndrome, which often involve artificial tears or anti-inflammatory medications, autologous serum tears with hyaluronate offer a unique approach. This treatment uses a patient's own blood to create tears enriched with natural growth factors and proteins, promoting healing and moisture retention. Additionally, the inclusion of sodium hyaluronate, a component known for its lubrication and hydration properties, sets it apart from conventional therapies. Researchers are excited because this personalized method could provide more effective and longer-lasting relief by directly addressing the underlying causes of dryness and irritation.

Studies have shown that eye drops made from a person's own blood, known as autologous serum eye drops (ASEDs), effectively treat moderate-to-severe dry eye syndrome. These drops help keep the eyes moist and aid in healing the eye's surface. Research found that people using ASEDs experienced significant symptom improvement. In this trial, one eye of each participant will receive autologous serum tears combined with sodium hyaluronate, a common ingredient in artificial tears, which has also been shown to alleviate dry eye symptoms when used alone. Combining sodium hyaluronate with ASEDs is believed to enhance these benefits, potentially providing even better relief and comfort for those with dry eyes. The fellow eye will receive autologous serum tears with balanced saline solution, allowing for a comparison of the two treatments.¹³⁵⁶⁷