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
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. * OSDI score ≥ 25 and/or and OSDI-6 score \> 6 at the screening visit * Presence of at least two of the following clinical signs in the same ey…
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
Location
- Bascom Palmer Eye InstituteMiami, Florida