Comparing Autologous Serum Tears With and Without Sodium Hyaluronate for Treating Moderate-to-Severe Dry Eye Disease in Adults

What this Trial Is About

Researchers are investigating if adding sodium hyaluronate, a moisturizing ingredient commonly found in artificial tears, improves the effectiveness of autologous serum eye drops for treating moderate-to-severe dry eye disease. The study compares the new combination against the traditional autologous serum tears diluted with balanced salt solution. Each participant will use the enhanced drops in one eye and the standard drops in the other to evaluate comfort, relief, and healing on the eye surface. Participants will continue their usual dry eye treatments throughout the study. One eye will receive autologous serum tears diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears, while the other eye will receive autologous serum tears diluted to 50% with balanced saline solution. Both treatments are applied four times daily for three months. The study is randomized, double-blind, and controlled, focusing on the effects of these formulations. During the study, participants will undergo several assessments including symptom scores with the Ocular Surface Disease Index, tear production tests, tear break-up time, corneal and conjunctival staining, confocal microscopy, keratograph measurements, and visual acuity checks at baseline and at weeks 4, 8, and 12. These tests will measure eye health, tear film stability, and nerve and cellular changes. The trial spans approximately three months of treatment with ongoing monitoring to evaluate outcomes and safety.

Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye