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

NCT07413172 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 20251145
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye; Eye Diseases; Eyes Dry Chronic

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

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.

Biological: Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate); Other: Standard of Care (SOC) Treatment

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.

Biological: Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS); Other: Standard of Care (SOC) Treatment

Interventions

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.

Autologous Serum Tears + Sodium Hyaluronate (Eye A)

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.

Autologous Serum Tears + Balanced Saline Solution (Eye B)

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

Autologous Serum Tears + Balanced Saline Solution (Eye B); Autologous Serum Tears + Sodium Hyaluronate (Eye A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Eye Diseases

Interventions

Hyaluronic Acid; Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sotiria Palioura, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos Christodoulou

CONTACT

(561) 560-1657; kxc1149@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Ophthalmology

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)