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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07413172
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Dry Eye
  • Eye Diseases
  • Eyes Dry Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate) — BIOLOGICAL
    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) — 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.
  • Standard of Care (SOC) Treatment — OTHER
    Participants will continue their standard-of-care treatment for dry eye disease as outlined in the protocol. SOC may vary per clinician judgment

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

OSDI (Ocular Surface Disease Index) Symptom Score (0-100) [ Time Frame: Baseline, Approximately 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bascom Palmer Eye InstituteMiamiFlorida33136
Konstantinos Christodoulou
[email protected]
(561) 560-1657
Sotiria Palioura, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Bascom Palmer Eye Institute· Miami, FL

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