Xiidra + Vevye for Dry Eye Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of two treatments, Vevye and Xiidra (both eye drops), for individuals with dry eye disease. The study will compare the effects of these treatments on people with dry eye symptoms to those without the condition. Participants should have experienced dry eye symptoms for at least six months and either used or wanted to use eye drops recently. Healthy volunteers without dry eye symptoms are also needed for comparison. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used ocular anti-inflammatory or immunosuppressive agents in the 3 months before the trial.
What is the safety track record for these treatments?
Research shows that Vevye and Xiidra are generally safe for treating dry eye disease.
For Vevye, studies indicate it is well-tolerated. About 8% of patients reported irritation at the application site, and 3% noticed a temporary decrease in vision. Most people did not experience serious side effects. Vevye also has a good long-term safety record, with patients using it for up to a year without major issues.
Xiidra is also considered safe and has been shown to improve dry eye symptoms in several studies. Some users might experience mild side effects, but serious problems are rare.
Both treatments are approved for dry eye disease, indicating a strong safety record.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments, Vevye and Xiidra, because they offer unique approaches to managing dry eye syndrome. Vevye stands out due to its specific formulation aimed at alleviating both evaporative and aqueous deficient dry eye symptoms with targeted topical application. Xiidra, on the other hand, works by inhibiting a key molecule involved in the eye's inflammatory response, potentially providing relief faster than some existing treatments like artificial tears or corticosteroids. Both treatments, applied directly to the eye, are designed to address the underlying causes of dry eye rather than just alleviating symptoms, making them promising options for patients seeking more effective relief.
What evidence suggests that this trial's treatments could be effective for dry eye syndrome?
This trial will compare the effectiveness of Vevye and Xiidra for treating dry eye syndrome. Studies have shown that Vevye, which contains cyclosporine, reduces dryness and blurry vision over a year. Patients using Vevye report less eye discomfort and clearer vision. Participants in this trial may receive Vevye as part of their treatment. Xiidra, another treatment option in this trial, can reduce dry eye symptoms in as little as two weeks, with improvements continuing for up to 12 weeks. Clinical studies have shown that Xiidra significantly reduces eye dryness and effectively manages DED symptoms in most patients. Both treatments are supported by strong clinical evidence demonstrating their benefits in managing dry eye symptoms.26789
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for individuals with moderate to severe dry eye disease (DED) who have used or wanted to use lubricant eye drops in the last 3 months. Participants should need prescription medication for DED and have had symptoms for at least 6 months. Healthy volunteers without DED can also join. People with recent isotretinoin use, ocular anti-inflammatory treatment, intraocular injections, high eye pressure, immunosuppressive implants, contact lens use within a month, recent allergic conjunctivitis or uncontrolled diseases cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants with dry eye disease receive either Vevye® or Xiidra® for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vevye
- Xiidra
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University