Skip to main content
Dry EyeVision and hearingBiologicalPhase 2

What this study is

This study aims to find out whether adding sodium hyaluronate, a moisturizing ingredient commonly found in artificial tears, makes autologous serum eye drops more effective for treating moderate-to-severe dry eye disease. Each participant will use one version of the drops in one eye and the standard version in the other eye. The goal is to see if the new combination provides better relief, comfort, and eye surface healing compared to the traditional formulation.

What's being tested

  • Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate)

    Intervention · BIOLOGICAL

    Autologous serum tears prepared from the participant's own blood, diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears, and administered to the randomized study eye.

  • Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)

    Intervention · BIOLOGICAL

    Autologous serum tears prepared from the participant's own blood, diluted to 50% with Balanced Saline Solution, and administered to the contralateral randomized study eye.

  • Standard of Care (SOC) Treatment

    Intervention · OTHER

    Participants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment

Study details

Official title
The Effect of Autologous Serum Tears Diluted to 50% With 0.2% Sodium Hyaluronate-Containing Preservative-Free Artificial Tears Versus Autologous Serum Tears Diluted to 50% With Balanced Salt Solution in Patients With Moderate-to-Severe Dry Eye Disease: A Prospective, Double-Blind, Randomized, Controlled, Contralateral-Eye Study
Sponsor
University of Miami
Conditions
Dry Eye · Eye Diseases · Eyes Dry Chronic
Enrolling
20 people
Starts
2026-03
Est. completion
2028-03
Design
Double-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗