Evaluation of BTV100 in Subjects With Dry Eye Disease

Last updated: January 18, 2025
Sponsor: BioTheraVision, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Dry Eyes

Dry Eye Disease

Sjogren's Syndrome

Treatment

BTV100 Mid dose

BTV100 Low dose

Placebo

Clinical Study ID

NCT06543303
BTV100-CS201
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 visitsduring 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 clinicaldiagnosis or a self-reported history of subjective complaints for at least 6 monthsprior to the screening visit, and meet all the following criteria in at least oneeye (the same eye) at Visit 1 and Visit 2:

Exclusion

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: Topicalophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine andtacrolimus), including Restasis® (cyclosporine) and Cequa® (cyclosporine)

  3. Current use of contact lenses or anticipated use during the study.

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: BTV100 Mid dose
Phase: 2
Study Start date:
December 31, 2024
Estimated Completion Date:
February 15, 2026

Study 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).

Connect with a study center

  • Cataract and Eye Surgery Centre, Victoria

    Doncaster East, Victoria
    Australia

    Active - Recruiting

  • Sydney Eye Hospital

    Sydney,
    Australia

    Active - Recruiting

  • Chang Gung Memorial Hospital-Kaohsiung Branch

    Kaohsiung,
    Taiwan

    Active - Recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung,
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital-LinKou Branch

    Taoyuan,
    Taiwan

    Active - Recruiting

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