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

The Effect of Autologous Serum Tears Diluted to 50% With 0.2% Sodium Hyaluronate-Containing Preservative-Free Artificial Tears Versus Autologous Serum Tears Diluted to 50% With Balanced Salt Solution in Patients With Moderate-to-Severe Dry Eye Disease: A Prospective, Double-Blind, Randomized, Controlled, Contralateral-Eye Study

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 Overview

• Status: Not yet recruiting
• Conditions: Eye Diseases; Dry Eye; Eyes Dry Chronic
• Intervention / Treatment: Biological: Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate); Other: Standard of Care (SOC) Treatment; Biological: Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Konstantinos Christodoulou; Phone Number: (561) 560-1657; Email: kxc1149@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute
      • Contact: Konstantinos Christodoulou; Phone Number: (561) 560-1657; Email: kxc1149@miami.edu
      • Principal Investigator: Sotiria Palioura, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous Serum Tears + Sodium Hyaluronate (Eye A); 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.	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.; 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
Active Comparator: Autologous Serum Tears + Balanced Saline Solution (Eye B); 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.	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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Sotiria Palioura, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Eye Diseases; Dry Eye Syndromes; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Carbohydrates; Quality Indicators, Health Care; Glycosaminoglycans; Polysaccharides; Hyaluronic Acid; Standard of Care; Therapeutics
• Other Study ID Numbers: 20251145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No