Reproxalap for Dry Eye Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new eye drop medicine, Reproxalap Ophthalmic Solution, for individuals with dry eye disease. The goal is to evaluate Reproxalap's effectiveness compared to a placebo (a solution with no active ingredient) and ensure its safety. Participants will apply the eye drops six times over two days. This trial suits those who have experienced eye discomfort and have used or considered using eye drops for dry eyes in the past six months. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.
Do I need to stop taking my current medications for the trial?
Yes, you will need to stop using any topical eye medications, except for artificial tears, for the duration of the trial. If you are on systemic corticosteroids or other immunomodulators, you must stop them at least 14 days before starting the trial.
Is there any evidence suggesting that Reproxalap Ophthalmic Solution is likely to be safe for humans?
Research has shown that Reproxalap Eye Drops have been tested on over 2,900 people. These studies found no safety problems. Some participants experienced mild and temporary irritation at the application site, but this was the only reported issue. This indicates that Reproxalap is generally well-tolerated by most people.12345
Why do researchers think this study treatment might be promising for dry eye disease?
Unlike the standard treatments for dry eye syndrome, which often include artificial tears and anti-inflammatory medications, Reproxalap is unique because it targets the underlying inflammation through a novel mechanism. Reproxalap uses an aldehyde-trapping agent that reduces the inflammatory response in the eye, potentially offering quicker relief from symptoms. Researchers are excited about Reproxalap because it has shown promise in delivering noticeable results in just a couple of days, which is faster than many existing options. This rapid action could significantly improve comfort and quality of life for people suffering from dry eye syndrome.
What evidence suggests that Reproxalap might be an effective treatment for Dry Eye Disease?
Studies have shown that reproxalap eye drops effectively treat dry eye disease. In trials, they improved symptoms such as eye redness, discomfort, and tear production compared to a placebo. Participants in this trial will receive either the Reproxalap Ophthalmic Solution or a Vehicle Ophthalmic Solution as a placebo comparator. One study found that reproxalap significantly reduced eye discomfort, a primary concern for people with dry eyes. Researchers have studied over 1,800 patients, and no major safety issues have been reported. This evidence suggests that reproxalap could be a promising option for managing dry eye symptoms.12467
Are You a Good Fit for This Trial?
This trial is for individuals with Dry Eye Disease, a condition where eyes don't produce enough tears or the right quality of tears. Participants should have a confirmed diagnosis and meet other study requirements not specified here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Reproxalap Ophthalmic Solution or Vehicle Ophthalmic Solution six times over two consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Reproxalap Ophthalmic Solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aldeyra Therapeutics, Inc.
Lead Sponsor