NCT07413172 Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye
| NCT ID | NCT07413172 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Miami |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-07-21 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-07-21 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Sotiria Palioura, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07413172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07413172 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07413172 currently recruiting?
Yes, NCT07413172 is actively recruiting participants. Contact the research team at kxc1149@miami.edu for enrollment information.
Where is the NCT07413172 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07413172 clinical trial?
NCT07413172 is sponsored by University of Miami. The principal investigator is Sotiria Palioura, MD at University of Miami. The trial plans to enroll 20 participants.