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Recruiting NCT06543303

Evaluation of BTV100 in Subjects With Dry Eye Disease

Phase II Interventional Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BTV100 Low dose, BTV100 Mid dose, BTV100 High dose, Placebo.
Who it may be relevant to
Registry conditions: Dry Eye. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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).

Interventions

  • Drug BTV100 Low dose
    1% Cevimeline Ophthalmic Solution
  • Drug BTV100 Mid dose
    2% Cevimeline Ophthalmic Solution
  • Drug BTV100 High dose
    4% Cevimeline Ophthalmic Solution
  • Drug Placebo
    Placebo

Primary outcome measures

  • Schirmer test [Time frame: Day 85]
Secondary outcome measures (1)
  • Schirmer test [Time frame: Day 15, 29, 57 and 85.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 4 centers
  • Chang Gung Memorial Hospital-Kaohsiung Branch — Kaohsiung City
  • Kaohsiung Veterans General Hospital — Kaohsiung City
  • Taipei Veterans General Hospital — Taipei
  • Chang Gung Memorial Hospital-LinKou Branch — Taoyuan
Australia · 2 centers
  • Cataract and Eye Surgery Centre, Victoria — Doncaster East
  • Sydney Eye Hospital — Sydney

Identifiers

NCT: NCT06543303 · BTV100-CS201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗