Recruiting
Phase 2

Sodium Hyaluronate

Sponsor:

University of Miami

Code:

NCT07413172

Conditions

Dry Eye

Eye Diseases

Eyes Dry Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate)

Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS)

Standard of Care (SOC) Treatment

Study Details

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

Study ID

NCT07413172

Start date

Jul 21, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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

Primary outcome measure

  • OSDI (Ocular Surface Disease Index) Symptom Score (0-100) [ Time Frame: Baseline, Approximately 12 weeks ]
  • OSDI (Ocular Surface Disease Index)-6 Symptom Score (0-12) [ Time Frame: Baseline, Approximately 12 weeks ]
  • Tear production (mm of wetting in 5 Minutes) [ Time Frame: Baseline, week 4,week 8,week 12 ]
  • Tear Break Up Time (Seconds) [ Time Frame: Baseline, week 4,week 8,week 12 ]
  • Corneal Fluorescein Staining (National Eye Institute Score (NEI) 0-15) [ Time Frame: Baseline, week 4,week 8,week 12 ]
  • Conjunctival Lissamine Green Staining (NEI Score 0-18) [ Time Frame: Baseline, week 4,week 8,week 12 ]
  • In Vivo Confocal Microscopy Parameters (Quantitative Cellular and Nerve Metrics) [ Time Frame: Baseline, week 4,week 8,week 12 ]
  • Keratograph 5M Measurement: Non-Invasive Keratographic Break-Up Time (Seconds) [ Time Frame: Baseline, week 4, week 8, week 12 ]
  • Keratograph 5M Tear Meniscus Height (mm) [ Time Frame: Baseline, week 4, week 8, week 12 ]
  • Keratograph 5M Measurement: Meibography Grade [ Time Frame: Baseline, week 4, week 8, week 12 ]
  • Visual Acuity (logMAR Units) [ Time Frame: Baseline, week 4, week 8, week 12 ]

Central Contacts and Locations

Central contacts

Konstantinos Christodoulou

(561) 560-1657kxc1149@miami.edu

Locations

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Konstantinos Christodoulou

(561) 560-1657kxc1149@miami.edu

Principal Investigator:

Sotiria Palioura, MD

More Information

Sponsor

University of Miami

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-24.