Clinical trial NCT06543303: Evaluation of BTV100 in Subjects With Dry Eye Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: BioTheraVision, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-masked, randomized, parallel
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: At the screening visit/Visit 1 (Day 1 minus 14 days), subjects who are eligible according to the inclusion and exclusion criteria will begin a 14-day run-in period during which they will self-administer 1 drop of single-masked vehicle to each eye twice daily (BID), morning and evening (at least 6-hour interval). At the time of the screening visit/Visit 1, subjects will be instructed to discontinue all over the counter (OTC) and prescription topical ophthalmic medications except for the vehicle or study drug throughout the study.

At Baseline/Visit 2 (Day 1), subjects who continue fulfilling inclusion/exclusion criteria will be randomized to study drug or vehicle.

Approximately120 subjects will be randomized. Subjects will be randomized to one of the following 4 treatment groups. Following randomization, subjects being masked to treatment assignments will be instructed to self-administer 1 drop of investigational product (IP) into each eye twice daily, morning and evening (at least 6-hour interval). Subjects will be instructed to return to the clinic to be evaluated at Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), and Day 85 (Visit 6).

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.

Primary outcomes:
measure: Schirmer test
timeFrame: Day 85
Secondary outcomes:
measure: Schirmer test
timeFrame: Day 15, 29, 57 and 85.
Other outcomes:
Locations:
city: Doncaster East
country: Australia
facility: Cataract and Eye Surgery Centre, Victoria
state: Victoria
city: Sydney
country: Australia
facility: Sydney Eye Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital-Kaohsiung Branch
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital-LinKou Branch
Study officials:
affiliation: BioTheraVision, Inc.
name: Mulan Lee, PhD
role: STUDY_DIRECTOR
References: