Vevye + Flarex for Dry Eye Syndrome

(FLARE-VEV Trial)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of combining two eye drops, Vevye and Flarex, for treating moderate to severe dry eye disease. Participants will apply Vevye twice daily and Flarex four times daily for one month. This trial may suit adults experiencing moderate to severe dry eyes. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using topical eye medications or systemic medications that cause dry eye, you may need to stop those before participating.

What is the safety track record for these treatments?

Research has shown that Vevye, an eye drop solution, is generally safe for long-term use. In studies, most participants tolerated it well, with only 8% experiencing mild reactions like discomfort at the application site. A small number, about 3%, noticed a temporary decrease in vision, but this effect did not persist.

Flarex, another type of eye drop, also maintains a good safety record, though a few important considerations exist. While effective, long-term use might increase eye pressure, potentially leading to glaucoma, a condition that can harm the eye's nerve. It might also cause cataracts, which cloud the eye's lens. However, these issues are more likely with very long-term use, and doctors closely monitor these risks.

Both treatments have FDA approval for other uses, which supports their safety for treating dry eye syndrome.12345

Why are researchers enthusiastic about this study treatment?

Unlike most treatments for dry eye syndrome that typically focus on lubrication or inflammation reduction, Vevye + Flarex offers a unique combination approach. Vevye contains cyclosporine, an active ingredient that helps increase tear production by modulating the immune response, while Flarex, with fluorometholone acetate, targets inflammation directly. Researchers are excited because this dual-action therapy may provide more comprehensive relief, addressing both tear production and inflammation simultaneously, potentially leading to faster and more effective symptom improvement.

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

Research has shown that Vevye, an eye drop containing cyclosporine, effectively treats dry eye disease. It reduced eye dryness and improved blurry vision for many patients in just 29 days. Continued use for a year maintained these benefits, reducing symptoms and enhancing eye health. Flarex, another eye drop, reduces eye swelling and quickly eased inflammation for most users, sometimes within two weeks. In this trial, participants will receive a combination of Vevye and Flarex to relieve dry eye disease by addressing both dryness and swelling.13456

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who have moderate to severe dry eye disease. Participants must be able to give consent, and women of childbearing age need to use contraception.

Inclusion Criteria

I am an adult with moderate to severe dry eye and can give informed consent.
No eligibility criterion provided.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline

Initial assessment and start of treatment with Vevye and Flarex

1 day
1 visit (in-person)

Treatment

Participants receive Vevye twice daily and Flarex four times daily

1 month
Multiple visits (Day 3, Week 1, Month 1)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Flarex
  • Vevye

Trial Overview

The study tests the safety and effectiveness of using Vevye (cyclosporine eye drops) twice daily together with Flarex (a steroid eye drop) four times daily in people with dry eye over one month.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Combination Therapy ArmExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Canyon City Eyecare

Lead Sponsor

Trials
1
Recruited
60+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26520171/

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