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NOT YET RECRUITING
NCT07413172
PHASE2

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

Sponsor: University of Miami

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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

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.

OTHER

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