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

Phase 2Not Yet RecruitingNCT07413172

University of Miami20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Eye Diseases Eyes Dry Chronic

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.