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

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University of Rochester

Status

Begins enrollment in 3 months

Conditions

Dry Eye Syndromes

Treatments

Other: Platelet Rich Plasma Tear Drops
Other: Platelet Poor Plasma Tear Drops

Study type

Interventional

Funder types

Other

Identifiers

NCT05121493
STUDY00004552

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must be diagnosed with clinically significant dry eye.
  • Subjects have no active ocular disease or allergic conjunctivitis.
  • Subjects must not be using any topical ocular medications within two weeks prior to enrollment.
  • Subjects must be willing and able to follow instructions.
  • Subjects must have voluntarily agreed to participate in the study by signing the statement of informed consent.
  • Subjects must meet plasma donor criteria as established by University of Rochester Transfusion Medicine & Blood Bank.

Exclusion criteria

  • Is pregnant at the time of enrolment in the study determined by urine pregnancy test.
  • Is currently on a course of antibiotics
  • Is considered by the Investigator to not be a suitable candidate for participation and are not at risk for glaucoma.
  • Is considered by the University of Rochester Transfusion Medicine & Blood Bank not a suitable candidate for blood donation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups

Platelet Poor Plasma Tear
Active Comparator group
Treatment:
Other: Platelet Poor Plasma Tear Drops
Platelet Rich Plasma Tears
Experimental group
Treatment:
Other: Platelet Rich Plasma Tear Drops

Trial contacts and locations

1

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Central trial contact

James Aquavella, MD

Data sourced from clinicaltrials.gov

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