Evaluating a new eye drop treatment for dry eye disease

A Phase 2, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Efficacy and Safety of Cevimeline Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

This study is testing a new eye drop treatment for dry eye disease to see if it helps people feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioTheraVision, Inc. (Industry-sponsored)
• Locations: 6 sites (Doncaster East, Victoria and 5 other locations)
• Trial ID: NCT06543303 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the efficacy, safety, and tolerability of BTV100, an ophthalmic solution, in individuals suffering from Dry Eye Disease (DED). Participants will undergo a 14-day run-in period where they will self-administer a vehicle solution before being randomized into one of four treatment groups: low, mid, or high doses of BTV100, or a placebo. Throughout the study, subjects will be monitored at multiple follow-up visits to evaluate their response to the treatment. The study aims to provide insights into the potential benefits of BTV100 compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with moderate to severe dry eye disease and a history of symptoms for at least six months.

Not a fit: Patients with known hypersensitivity to the study drug or those currently using contact lenses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from dry eye disease by providing a new effective therapy.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating dry eye disease with novel therapies.

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.

Where this trial is running

Doncaster East, Victoria and 5 other locations

• Cataract and Eye Surgery Centre, Victoria — Doncaster East, Victoria, Australia (Recruiting)
• Sydney Eye Hospital — Sydney, Australia (Recruiting)
• Chang Gung Memorial Hospital-Kaohsiung Branch — Kaohsiung City, Taiwan (Recruiting)
• Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
• Chang Gung Memorial Hospital-LinKou Branch — Taoyuan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Mulan Lee, PhD

Conditions Dry Eye