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NCT Number: NCT07413172

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

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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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Eyes Dry Chronic Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Konstantinos Christodoulou

CONTACT

[email protected]

(561) 560-1657

Sotiria Palioura, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Konstantinos Christodoulou

CONTACT

[email protected]

(561) 560-1657

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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