A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

Launched by ALDEYRA THERAPEUTICS, INC. · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new eye drop treatment called 0.25% Reproxalap for people with Dry Eye Disease, a condition where the eyes do not produce enough moisture, leading to discomfort and irritation. The trial aims to find out if this treatment is safe and effective for managing dry eye symptoms. It is currently open for recruitment and is looking for participants aged 18 and older, who have experienced dry eye symptoms and have used eye drops in the last six months.

To participate, individuals must not have any active eye infections or inflammation, and they should not have used contact lenses or certain eye medications recently. Participants will be randomly assigned to receive either the new eye drop or a placebo (a treatment without active ingredients) without knowing which one they are receiving. Throughout the trial, participants will be monitored for any side effects and how well the treatment works. If you're considering joining, it’s important to discuss it with your healthcare provider to see if you meet the eligibility criteria and to understand more about what participation involves.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • at least 18 years of age;
• • written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
• • history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
• Exclusion Criteria:
• • ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
• • contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
• • eye drops within 2 hours of Visit 1;
• • laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• • topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1