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RECRUITINGPhase 2INTERVENTIONAL

Evaluation of BTV100 in Subjects With 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).

Who May Be Eligible (Plain English)

Who May Qualify: 1. 18 years of age or older (regardless of gender). 2. Provide written willing to sign a consent form. 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: Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

BTV100 Low dose

1% Cevimeline Ophthalmic Solution

DRUG

BTV100 Mid dose

2% Cevimeline Ophthalmic Solution

DRUG

BTV100 High dose

4% Cevimeline Ophthalmic Solution

DRUG

Placebo

Placebo

Locations (6)

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