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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
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.
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.
Participants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment
Bascom Palmer Eye Institute
Miami, Florida, United States
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 weeks
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 weeks
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 12
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 12
Corneal Fluorescein Staining (National Eye Institute Score (NEI) 0-15)
Corneal staining severity graded using the NEI scale (0-15), with higher scores indicating more extensive staining
Time frame: Baseline, week 4,week 8,week 12
Conjunctival Lissamine Green Staining (NEI Score 0-18)
Conjunctival staining severity graded using the NEI scale (0-18), with higher scores indicating more extensive staining.
Time frame: Baseline, week 4,week 8,week 12
In Vivo Confocal Microscopy Parameters (Quantitative Cellular and Nerve Metrics)
Quantitative assessment of corneal cellular structures and sub-basal nerve plexus morphology using in vivo confocal microscopy. Measured in mm/mm².
Time frame: Baseline, week 4,week 8,week 12
Keratograph 5M Measurement: Non-Invasive Keratographic Break-Up Time (Seconds)
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.
Time frame: Baseline, week 4, week 8, week 12
Keratograph 5M Tear Meniscus Height (mm)
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.
Time frame: Baseline, week 4, week 8, week 12
Keratograph 5M Measurement: Meibography Grade
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.
Time frame: Baseline, week 4, week 8, week 12
Visual Acuity (logMAR Units)
Uncorrected and best-corrected Visual Acuity measured using a standardized logMAR chart and reported in logMAR units
Time frame: Baseline, week 4, week 8, week 12
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