Evaluation of BTV100 in Subjects With Dry Eye Disease

Launched by BIOTHERAVISION, INC. · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new eye drop solution called BTV100 to see if it can help people with Dry Eye Disease (DED), a condition that causes discomfort and dryness in the eyes. The study will compare the effects of BTV100 to a placebo (a "dummy" treatment that does not contain the active drug) to determine how effective and safe it is for treating this condition.

To participate in the trial, you need to be at least 18 years old and have been experiencing moderate to severe dry eye symptoms for at least six months. You'll also need to be able to attend several study visits and follow the instructions given. Throughout the trial, participants will receive multiple doses of the eye drops and will be monitored for their reaction to the treatment. It's important to note that if you're currently using contact lenses or have taken certain medications recently for your eyes, you may not be eligible to join the study. This is an exciting opportunity to help researchers learn more about potential new treatments for dry eyes!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years of age or older (regardless of gender).
• • 2. Provide written informed consent.
• • 3. Willing and able to follow instructions and be available for required study visits during the study.
• • 4. Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes.
• 5. Ongoing moderate to severe Dry Eye Disease (DED) supported by a previous clinical diagnosis or a self-reported history of subjective complaints for at least 6 months prior to the screening visit, and meet all the following criteria in at least one eye (the same eye) at Visit 1 and Visit 2:
• Exclusion Criteria:
• • 1. Known hypersensitivity or contraindication to the study drug or its components.
• • 2. Within 28 days prior to the screening visit (Visit 1), have taken or used: Topical ophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine and tacrolimus), including Restasis® (cyclosporine) and Cequa® (cyclosporine)
• • 3. Current use of contact lenses or anticipated use during the study.