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Evaluation of BTV100 in Subjects With Dry Eye Disease

PHASE2NOT_YET_RECRUITING

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).

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • 18 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:
  • Exclusion criteria

  • 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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-11-15

    Primary completion: 2026-02-15

    Study completion finish: 2026-02-15

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT06543303

    Intervention or treatment

    DRUG: BTV100 Low dose

    DRUG: BTV100 Mid dose

    DRUG: BTV100 High dose

    DRUG: Placebo

    Conditions

    • Dry Eye

    Find a site

    Closest Location:

    Sydney Eye Hospital

    Research sites nearby

    Select from list below to view details:

    • Sydney Eye Hospital

      Sydney, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    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
    PLACEBO_COMPARATOR: Vehicle
    • Vehicle
    DRUG: Placebo
    • Placebo

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Schirmer testChange from baseline in unanesthetized Schirmer test of study eyeDay 85

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Schirmer testProportion of subjects with an increase in unanesthetized Schirmer of 10 mm or more for study eyeDay 15, 29, 57 and 85.

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Evaluation of BTV100 in Subjects With Dry Eye Disease

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