Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate)
Biological/VaccineAutologous 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 - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)
Biological/VaccineAutologous serum tears prepared from the participant's own blood, diluted to 50% with Balanced Saline Solution, and administered to the contralateral randomized study eye.
Standard of Care (SOC) Treatment
Other interventionParticipants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Autologous Serum Tears + Sodium Hyaluronate (Eye A)Experimental treatment 2 interventions
Group B: Autologous Serum Tears + Balanced Saline Solution (Eye B)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
OSDI (Ocular Surface Disease Index) Symptom Score (0-100)
Change in dry eye symptom severity measured using the Ocular Surface Disease Index (OSDI) questionnaire, scored from 0 to 100, with higher scores indicating greater symptom severity.
Time frame
Baseline, Approximately 12 weeks2
OSDI (Ocular Surface Disease Index)-6 Symptom Score (0-12)
Change in dry eye symptom severity measured using the Ocular Surface Disease Index (OSDI-6)questionnaire, scored from 0 to 12, with higher scores indicating greater symptom severity.
Time frame
Baseline, Approximately 12 weeks3
Tear production (mm of wetting in 5 Minutes)
Tear production measured using anesthetized Schirmer's test, reported as millimeters of strip wetting over 5 minutes.
Time frame
Baseline, week 4,week 8,week 124
Tear Break Up Time (Seconds)
Mean fluorescein Tear Break Up Time Using slit-lamp and fluorescein dye to review cornea and determine how long it takes for dry spots to occur. Calculated as the average of three measurements and reported in seconds
Time frame
Baseline, week 4,week 8,week 12Sponsors and contacts
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Source ClinicalTrials.gov