Autologous Serum Tears with Hyaluronate vs Standard Serum Tears for Moderate-to-Severe Dry Eye

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2 trial, participants with aqueous-deficient dry eye due to conditions like Sjögren's syndrome or graft-versus-host disease will use two different eye drop formulations: 50% autologous serum tears with 0.2% sodium hyaluronate in one eye and 50% autologous serum tears with balanced saline solution in the other eye, with standard-of-care treatment as a reference. The study uses a within-subject design to compare outcomes such as comfort, surface healing, and tear film stability over time. Eligible adults must have chronic moderate-to-severe symptoms and specific clinical signs, and they must be willing to self-administer serum tears at least twice daily. Primary endpoints likely focus on symptom relief and ocular surface healing, while safety and tolerability are monitored throughout. The lead sponsor is the University of Miami, with Bascom Palmer Eye Institute as the site.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bascom Palmer Eye Institute
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Sotiria Palioura, MD — University of Miami
• Study coordinator: Konstantinos Christodoulou
• Email: kxc1149@miami.edu
• Phone: (561) 560-1657

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.