Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Age <18 years old.
Cognitive impairment or psychiatric condition that precludes informed consent or the ability to comply with study procedures.
Any clinical condition identified at screening that, in the opinion of the treating physician, is clinically significant and would contraindicate safe participation in the study.
Any condition or treatment known to affect the signs and symptoms of DED, including pregnancy, regular use of contact lenses, recent diagnosis of ocular allergy, infection, or inflammation, or recent ocular surgery within 6 months.
Trial design
Treatments tested in this trial
- Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate)
- Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)
- Standard of Care (SOC) Treatment
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov