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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

TREATMENT

Phase

PHASE2

Trial ID

NCT06543303

Intervention or treatment

DRUG: BTV100 Low dose

DRUG: BTV100 Mid dose

DRUG: BTV100 High dose

DRUG: Placebo

Conditions

• Dry Eye

Condition: Dry Eye
DRUG: BTV100 Low dose and other drugs
Sydney, Not Specified, Australia
Sponsor: BioTheraVision, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Sydney Eye Hospital

Research sites nearby

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Sydney Eye Hospital
Sydney, Not Specified, Australia

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

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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.

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

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