RecruitingPhase 2NCT07413172

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

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

Enrollment

20 participants

Start Date

Jul 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate), Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS), and others for people with dry eye, eye diseases, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous 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.

BIOLOGICALBiological - 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.

OTHERStandard 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

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NCT07413172


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