15 Participants Needed

Plasma Tear Drops for Dry Eye Syndrome

JA
Overseen ByJames Aquavella, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You must stop using any eye drops or topical eye medications at least two weeks before joining the study. The protocol does not specify about other medications, so it's best to discuss with the study team.

Is it safe to use plasma tear drops for dry eye syndrome?

The research on platelet-related products suggests that while platelet storage and transfusion can have adverse effects, these are mostly related to transfusion procedures and not directly applicable to plasma tear drops. Plateletpheresis procedures, which are related to the collection of platelets, are generally considered safe with few adverse events reported.12345

How is the treatment with plasma tear drops different from other treatments for dry eye syndrome?

Plasma tear drops, including platelet-rich plasma (PRP) and platelet-poor plasma, are unique because they use components from the patient's own blood, rich in anti-inflammatory agents and growth factors, to help repair the eye's surface, unlike standard artificial tears that only provide temporary moisture.678910

What data supports the effectiveness of the treatment Platelet Poor Plasma Tear Drops and Platelet Rich Plasma Tear Drops for Dry Eye Syndrome?

Research shows that platelet-rich plasma, which is rich in healing agents, can help repair the eye surface and improve symptoms in people with dry eye disease. Studies comparing it to artificial tears found it to be effective in reducing symptoms and improving eye health.678911

Are You a Good Fit for This Trial?

This trial is for individuals with clinically significant dry eye who have no other active eye diseases or allergies. Participants must not be using any eye medications two weeks prior to joining, meet blood donation criteria, and agree to follow the study's instructions. Pregnant individuals or those on antibiotics are excluded.

Inclusion Criteria

You have been diagnosed with a serious case of dry eye.
You don't have any eye problems or allergies that affect your eyes.
You do not have any current eye diseases or allergies affecting your eyes.
See 4 more

Exclusion Criteria

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
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive platelet rich plasma drops or plasma tears without platelets to treat dry eye syndrome

12 weeks
Up to 4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Platelet Poor Plasma Tear Drops
  • Platelet Rich Plasma Tear Drops
Trial Overview The study is testing if Platelet Rich Plasma (PRP) Drops can improve dry eyes compared to Platelet Poor Plasma Drops. It's a double-masked trial at Flaum Eye Institute where neither participants nor researchers know who receives which type of drop until after the results are collected.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Platelet Rich Plasma TearsExperimental Treatment1 Intervention
Group II: Platelet Poor Plasma TearActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

Citations

Platelet-rich plasma for treating dry eye disease - A systematic review and meta-analysis. [2023]
Effect of Autologous Platelet-Rich Plasma Drops in the Treatment of Ocular Surface Disease. [2023]
Efficacy and safety of treatment of hyposecretory dry eye with platelet-rich plasma. [2019]
Autologous platelet-rich plasma eye drop versus artificial tear eye drop for symptomatic dry eye disease: A prospective comparative interventional study. [2023]
Treatment of Dry Eye Disease with Autologous Platelet-Rich Plasma: A Prospective, Interventional, Non-Randomized Study. [2020]
Prolonged platelet storage associated with increased frequency of transfusion-related adverse events. [2018]
In vitro and in vivo evaluation of apheresis platelets stored for 5 days in 65% platelet additive solution/35% plasma. [2014]
In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution. [2019]
Clinical Indications and Adverse Reactions of Platelet Apheresis. [2015]
Alarmed or unalarmed!! Donor red cell lysis during plateletpheresis procedure. [2018]
Symptomatic dry eye treatment with autologous platelet-rich plasma. [2022]
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