Autologous Serum Tears With Hyaluronate for Dry Eye Syndrome

Overseen By Konstantinos Christodoulou

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Miami

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sotiria Palioura, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

* Age ≥ 18 years old

* Formal diagnosis of one of the following conditions associated with aqueous-deficient dry eye disease: Sjögren's syndrome (primary or secondary), Mucous membrane pemphigoid, Graft-versus-host disease, Stevens-Johnson syndrome, Post-radiation lacrimal gland aqueous deficiency, or Neurotrophic keratitis

* Moderate-to-severe Dry Eye Disease (DED) symptoms for at least 6 months prior to study enrollment.

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Serum Tears with Hyaluronate

How Is the Trial Designed?

Group I: Autologous Serum Tears + Sodium Hyaluronate (Eye A) Experimental Treatment 2 Interventions

All participants will continue their standard-of-care treatment throughout the study. One eye of each participant will receive autologous serum tears diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears 4 times daily for 3 months.

Group II: Autologous Serum Tears + Balanced Saline Solution (Eye B) Active Control 2 Interventions

All participants will continue their standard-of-care treatment throughout the study. The fellow eye of each participant will receive autologous serum tears diluted to 50% with Balanced Saline Solution 4 times daily for 3 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+