Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT05121493
Status
Not Yet Recruiting

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Conditions

  • Dry Eye Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Platelet Poor Plasma Tear Drops — OTHER
    Participant blood will be drawn and processed by the University of Rochester Transfusion Medicine and Blood Bank. Processing will isolate the platelet free fraction of the blood plasma. After processing, plasma should contain ≤ 5% concentration of white blood cells (WBC), red blood cells (RBC), and platelets when compared to the concentration before processing.
  • Platelet Rich Plasma Tear Drops — OTHER
    Participant blood will be drawn and processed by the University of Rochester Transfusion Medicine and Blood Bank. Processing will isolate the platelet fraction of the blood plasma. After processing, plasma should contain ≤ 5% concentration of WBC and RBC and 100 x 10³ μl or ≥ 50% recovery of platelets when compared to the pre-platelet count.

Study Details

This is a single center double-masked study with up to four visits. Subjects who have been diagnosed with dry-eye syndrome at Flaum Eye Institute will be enrolled. The purpose of the study is to determine if using platelet rich plasma drops can improve clinically significant dry eye in patients and determine if there is a difference with using two different uses of the plasma tear drops: platelet rich plasma tears and plasma tears without platelets.

Key Dates

Start date
Oct 15, 2025
Status verified
Jul 2024
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

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

Arms

  • Active Comparator: Platelet Poor Plasma Tear
  • Experimental: Platelet Rich Plasma Tears

Primary Outcome Measure

Mean change in acuity [ Time Frame: baseline to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Flaum Eye Institute at the University of RochesterRochesterNew York14642
James Aquavella, MD
[email protected]
585-273-3937

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By research site
Flaum Eye Institute at the University of Rochester· Rochester, NY

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