Evaluation of BTV100 in Subjects With Dry Eye Disease

NCT06543303 | Recruiting Phase 2 FDA Drug

• 1 other identifier: BTV100-CS201
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 6

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).

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Schirmer test

  Change from baseline in unanesthetized Schirmer test of study eye

  Day 85

Secondary Outcomes (1)

• Schirmer test

  Day 15, 29, 57 and 85.

Study Arms (4)

BTV100 Low dose

EXPERIMENTAL

1% Cevimeline Ophthalmic Solution

Drug: BTV100 Low dose

BTV100 Mid dose

EXPERIMENTAL

2% Cevimeline Ophthalmic Solution

Drug: BTV100 Mid dose

BTV High dose

EXPERIMENTAL

4% Cevimeline Ophthalmic Solution

Drug: BTV100 High dose

Vehicle

PLACEBO COMPARATOR

Vehicle

Drug: Placebo

Interventions

BTV100 Low dose DRUG

1% Cevimeline Ophthalmic Solution

BTV100 Low dose

BTV100 Mid dose DRUG

2% Cevimeline Ophthalmic Solution

BTV100 Mid dose

BTV100 High dose DRUG

4% Cevimeline Ophthalmic Solution

BTV High dose

Placebo DRUG

Placebo

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older (regardless of gender).
• Provide written informed consent.
• Willing and able to follow instructions and be available for required study visits during the study.
• Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes.
• 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:

You may not qualify if:

• Known hypersensitivity or contraindication to the study drug or its components.
• 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)
• Current use of contact lenses or anticipated use during the study.

Sponsors & Collaborators

• BioTheraVision, Inc.: lead

Study Sites (6)

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 District, Taiwan

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Mulan Lee, PhD

  BioTheraVision, Inc.

  STUDY DIRECTOR

Central Study Contacts

Mulan Lee, PhD

CONTACT

714.679.8219; mlee@biotheravision.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-masked investigational product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked, randomized, parallel

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: December 31, 2024
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

TW (4); AU (2)