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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Serum Tears + Sodium Hyaluronate (Eye A) | Experimental | All participants will continue their standard-of-care treatment throughout the study. One eye of each participant will receive autologous serum tears diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears 4 times daily for 3 months. |
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| Autologous Serum Tears + Balanced Saline Solution (Eye B) | Active Comparator | All participants will continue their standard-of-care treatment throughout the study. The fellow eye of each participant will receive autologous serum tears diluted to 50% with Balanced Saline Solution 4 times daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | 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 | 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. |
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Inclusion Criteria:
Age ≥ 18 years old
Exclusion Criteria:
Age <18 years old.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konstantinos Christodoulou | Contact | (561) 560-1657 | kxc1149@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sotiria Palioura, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
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|
| Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS) | Biological | 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. |
|
| Standard of Care (SOC) Treatment | Other | Participants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment |
|
| 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. | 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. | 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. | 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. | 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 | Baseline, week 4, week 8, week 12 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D059039 | Standard of Care |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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