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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
  • 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

Recruiting Locations

Bascom Palmer Eye Institute
Miami, Florida 33136
Contact:
Konstantinos Christodoulou
(561) 560-1657
kxc1149@miami.edu

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

Konstantinos Christodoulou
(561) 560-1657
kxc1149@miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.