Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

Launched by ALCON RESEARCH · May 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new eye drop product designed to help people with dry eye disease, a condition that causes discomfort and blurry vision. The study aims to find out how safe and effective this new eye lubricant is for patients who have mild to moderate symptoms of dry eyes. If you're between the ages of 65 and 74 and are experiencing symptoms of dry eyes, you might qualify to participate in this trial.

To join, you'll need to be willing to stop using other eye drops and use only the study product as directed. It’s important that you can understand and sign an informed consent form, showing that you agree to take part. Throughout the study, you will have visits to monitor your condition and the effects of the eye drops. Keep in mind that if you are pregnant, breastfeeding, or have certain health issues that could complicate the study, you may not be eligible. This trial provides an opportunity to help advance treatments for dry eye disease while potentially improving your own eye comfort.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Willing and able to understand and sign an approved informed consent form.
• • Exhibit symptoms of dry eye at the Screening visit.
• • Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
• • Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.
• • Other protocol-defined inclusion criteria may apply.
• Key Exclusion Criteria:
• • Pregnant, breastfeeding, or planning to become pregnant during the study.
• • Ocular abnormalities that could adversely affect the safety or efficacy outcome.
• • Uncontrolled active systemic diseases.
• • Use of systemic medications known to cause dry eye.
• • Other protocol-defined exclusion criteria may apply.

Trial Officials