Plasma Tear Drops for Dry Eye Syndrome

Overseen By James Aquavella, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must not be taking: Topical ocular medications, Antibiotics

Disqualifiers: Pregnancy, Glaucoma risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests plasma tear drops to determine their effectiveness for dry eye syndrome. It compares two types of drops: one with platelets (tiny blood cells that aid healing) and one without. The goal is to identify which type more effectively eases dry eye symptoms. Individuals diagnosed with dry eye syndrome who aren't using eye medications might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatments for dry eye syndrome.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that platelet-rich plasma (PRP) drops are generally safe for treating dry eye syndrome. In one study, most patients noticed improvement in their dry eye symptoms after using PRP drops. Another study found that PRP drops were as effective and safe as other treatments for moderate to severe dry eye. Patients in these studies did not report any major side effects, indicating that PRP drops are well-tolerated.

The trial also tests platelet-poor plasma (PPP) drops. Specific safety data for PPP drops in treating dry eye is limited. However, since both treatments derive from blood plasma, they are generally considered safe.

Overall, research suggests these plasma treatments are safe options for people with dry eye syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about plasma tear drops for dry eye syndrome because they offer a novel approach to treatment. Unlike current options like artificial tears or prescription eye drops, these plasma-based drops use components derived from the patient's own blood, which could enhance healing and reduce inflammation. Platelet Rich Plasma (PRP) tears are especially promising as they are packed with growth factors that may accelerate tissue repair and improve eye lubrication. This personalized treatment could potentially offer more natural and effective relief for patients with dry eye syndrome.

What evidence suggests that this trial's treatments could be effective for dry eye syndrome?

This trial will compare the effectiveness of Platelet Rich Plasma (PRP) Tear Drops and Platelet Poor Plasma (PPP) Tear Drops in treating dry eye syndrome. Research has shown that both PRP and PPP eye drops may improve dry eye symptoms. Specifically, studies on PRP found that 87.5% of users experienced improvements in their symptoms and better healing of the eye surface. PRP eye drops enhance the health and stability of the eye surface, which is crucial for treating dry eyes. Similarly, PPP eye drops have demonstrated benefits for eye health, akin to PRP. Both treatments outperform standard artificial tears, suggesting they could effectively relieve dry eyes. Overall, these plasma-based treatments offer significant improvements for individuals with dry eye syndrome. ^{5 6 7 8 9}

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.

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

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?

Group I: Platelet Rich Plasma Tears Experimental Treatment 1 Intervention

Group II: Platelet Poor Plasma Tear Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9333043/

Autologous platelet-rich plasma eye drop versus artificial tear ... Autologous PRP treatment provides a greater improvement in signs and symptoms of DED patients as compared to AT treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10600870/

Randomized controlled trial on the efficacy and safety of ... The study comparing ASEDs to conventional artificial tears found that ASEDs significantly improved the ocular surface disease index score, tear break-up time, ...

3. cureus.com cureus.com/articles/367389-comparative-evaluation-of-autologous-platelet-rich-plasma-and-artificial-tears-for-treatment-of-chronic-evaporative-dry-eye-patients-a-prospective-interventional-study

Comparative Evaluation of Autologous Platelet-Rich ... These results suggest that PRP has a positive impact on ocular surface healing and tear film stability, as suggested by the CFS score and TBUT ...

4. frontiersin.org frontiersin.org/journals/ophthalmology/articles/10.3389/fopht.2023.1215848/full

Use of allogeneic platelet-rich plasma for the treatment ... Results: The symptoms and visual acuity improved significantly in all patients. There was a significant improvement in corneal sensitivity and a ...

5. mdpi.com mdpi.com/2077-0383/12/9/3126

The Comparison between the Composition of 100 ... The aim of the study was to compare the difference in composition between 100% autologous serum (AS) and 100% platelet-rich plasma (PRP) eye drops.

6. nature.com nature.com/articles/s41598-023-46671-2

Efficacy and safety of platelet-rich plasma and autologous ... We compared the efficacy and safety of autologous-serum (AS) and platelet-rich plasma (PRP) eye drops for dry eye (DE) treatment in primary ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5693817/

Treatment of Dry Eye Disease with Autologous Platelet ... After 6 weeks of monotherapy treatment with autologous PRP, dry eye symptoms improved in 322 (87.5%) cases. A decrease of CFS was observed in ...

8. bmjophth.bmj.com bmjophth.bmj.com/content/9/1/e001857

Efficacy of 100% autologous platelet-rich plasma and ... 100% APRP was not inferior to 100% AS in reducing dry eye symptoms and ocular surface staining in moderate-to-severe DED.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1367048424001395

Comparison of autologous serum and platelet-rich plasma ... Both treatments are equally effective in severe dry eye and persistent epithelial defects. Although, visual gain is higher in PRP, autologous serum may be ...