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Evaluation of BTV100 in Subjects With Dry Eye Disease

NCT06543303 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-22

No results posted yet for this 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).

Conditions

  • Dry Eye

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

Sponsors & Collaborators

  • BioTheraVision, Inc.

    lead INDUSTRY

Principal Investigators

  • Mulan Lee, PhD · BioTheraVision, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-02-15
Completion
2026-02-15
FDA Drug
Yes

Countries

  • Australia
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06543303 on ClinicalTrials.gov