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Autologous Serum Tears for Moderate-to-Severe Dry Eye

This study is testing if adding sodium hyaluronate to autologous serum tears (eye drops made from your own blood) makes them more effective for moderate-to-severe dry eye disease. You would use one version of the drops in one eye and a standard version in your other eye. Researchers want to see if the combination of 50% Autologous Serum Tears + 0.2% Sodium Hyaluronate provides better relief, comfort, and eye surface healing compared to 50% Autologous Serum Tears + Balanced Saline Solution. The study aims to enroll 20 participants who are at least 18 years old and have a formal diagnosis of certain conditions associated with aqueous-deficient dry eye disease. Success will be measured by changes in your dry eye symptoms and tear production over approximately 12 weeks.

Study design
This is an interventional study comparing two different formulations of autologous serum tears. It plans to enroll 20 participants.
What's involved
You would use different eye drop formulations in each eye and continue your standard dry eye treatment. Your dry eye symptoms and tear production will be measured at baseline, and then again at approximately 4, 8, and 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for approximately 12 weeks after starting the study.

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NCT07413172

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Miami
~20 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested: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

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
OSDI (Ocular Surface Disease Index) Symptom Score (0-100)
Measured over Baseline, Approximately 12 weeks
+10 more outcomes measured

Conditions

Dry Eye
Eye Diseases
Eyes Dry Chronic

Explore related trials

Benign Mucous Membrane PemphigoidDry eyesGraft Versus Host DiseaseNeurotrophic keratitisSjogren SyndromeStevens-Johnson Syndrome

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Sotiria Palioura, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Konstantinos Christodoulou
[email protected]
(561) 560-1657
Email the study team

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Eligibility criteria

Inclusion

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 eye, at the screening visit: Anesthetized Schirmer's test score 7 ≤ mm at 5 minutes, Tear Break up Time (TBUT) ≤ 7 seconds, Corneal fluorescein staining score ≥ 4 (maximum 15) as assessed by the National Eye Institute (NEI) grading scale 25, or Conjunctival lissamine green staining ≥ 3 (maximum 18) as assessed by the NEI grading scale
Desire to use autologous serum tears at least twice daily in the 2 weeks prior to screening visit.

Exclusion

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.
Patients with stable ocular surface disease or neurotrophic keratitis secondary to prior ocular surgery, chronic glaucoma therapy, or eyelid abnormalities may be included.

What this trial measures

  • OSDI (Ocular Surface Disease Index) Symptom Score (0-100)Baseline, Approximately 12 weeks

    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.

  • OSDI (Ocular Surface Disease Index)-6 Symptom Score (0-12)Baseline, Approximately 12 weeks

    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.

  • Tear production (mm of wetting in 5 Minutes)Baseline, week 4,week 8,week 12

    Tear production measured using anesthetized Schirmer's test, reported as millimeters of strip wetting over 5 minutes.

  • Tear Break Up Time (Seconds)Baseline, week 4,week 8,week 12

    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

  • Corneal Fluorescein Staining (National Eye Institute Score (NEI) 0-15)Baseline, week 4,week 8,week 12

    Corneal staining severity graded using the NEI scale (0-15), with higher scores indicating more extensive staining

  • Conjunctival Lissamine Green Staining (NEI Score 0-18)Baseline, week 4,week 8,week 12

    Conjunctival staining severity graded using the NEI scale (0-18), with higher scores indicating more extensive staining.

  • In Vivo Confocal Microscopy Parameters (Quantitative Cellular and Nerve Metrics)Baseline, week 4,week 8,week 12

    Quantitative assessment of corneal cellular structures and sub-basal nerve plexus morphology using in vivo confocal microscopy. Measured in mm/mm².

  • Keratograph 5M Measurement: Non-Invasive Keratographic Break-Up Time (Seconds)Baseline, week 4, week 8, week 12

    Non-invasive keratographic break-up time (NIKBUT) will be measured using the Keratograph 5M ocular surface imaging system. Participants will blink normally and then keep their eyes open while the device records the time in seconds until tear film break-up occurs. Higher values indicate greater tear film stability.

  • Keratograph 5M Tear Meniscus Height (mm)Baseline, week 4, week 8, week 12

    Tear meniscus height (TMH) will be measured using the Keratograph 5M non-invasive ocular surface imaging system. The Keratograph 5M software will automatically detect and calculate tear meniscus height in millimeters.

  • Keratograph 5M Measurement: Meibography GradeBaseline, week 4, week 8, week 12

    Meibography will be performed using the Keratograph 5M non-contact infrared imaging system to assess meibomian gland structure in the upper and lower eyelids. Meibography grading of meibomian gland dropout using a unitless 0-6 meiboscore scale.

  • Visual Acuity (logMAR Units)Baseline, week 4, week 8, week 12

    Uncorrected and best-corrected Visual Acuity measured using a standardized logMAR chart and reported in logMAR units