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Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
Sponsor: University of Miami
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-03
Completion Date
2028-03
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate)
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)
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
Participants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment
Locations (1)
Bascom Palmer Eye Institute
Miami, Florida, United States