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

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).

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Placebo; Drug: BTV100 Low dose; Drug: BTV100 Mid dose; Drug: BTV100 High dose

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).

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mulan Lee, PhD; Phone Number: 714.679.8219; Email: mlee@biotheravision.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Placebo; Placebo
Experimental: BTV100 Low dose; 1% Cevimeline Ophthalmic Solution	Drug: BTV100 Low dose; 1% Cevimeline Ophthalmic Solution
Experimental: BTV100 Mid dose; 2% Cevimeline Ophthalmic Solution	Drug: BTV100 Mid dose; 2% Cevimeline Ophthalmic Solution
Experimental: BTV High dose; 4% Cevimeline Ophthalmic Solution	Drug: BTV100 High dose; 4% Cevimeline Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer test	Change from baseline in unanesthetized Schirmer test of study eye	Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer test	Proportion of subjects with an increase in unanesthetized Schirmer of 10 mm or more for study eye	Day 15, 29, 57 and 85.

Collaborators and Investigators

• Sponsor: BioTheraVision, Inc.
• Investigators: Study Director: Mulan Lee, PhD, BioTheraVision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 18, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: BTV100-CS201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No