NCT07413172 · University of Miami
Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Autologous 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.
BIOLOGICAL
Biological - 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.
OTHER
Standard 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
Primary outcome measures
OSDI (Ocular Surface Disease Index) Symptom Score (0-100)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Grade
Time frame: Baseline, 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)
Time frame: Baseline, week 4, week 8, week 12
Uncorrected and best-corrected Visual Acuity measured using a standardized logMAR chart and reported in logMAR units
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 criteria
- 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.
Where
- Miami, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2026 · Source of record for eligibility and locations