Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)

February 24, 2026 updated by: Tarsus Pharmaceuticals, Inc.

A Randomized, Vehicle-Controlled, Multicenter, Double-Masked, Parallel, Phase 2 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of Lotilaner Ophthalmic Gel in Participants With Ocular Rosacea (KORE)

To evaluate lotilaner treatment in patients with ocular rosacea.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

To evaluate safety of lotilaner compared to vehicle control in the treatment of ocular rosacea.

Study Type

Interventional

Enrollment (Estimated)

155

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77027
        • Site
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older at the time of consent.
  • Has moderate to severe ocular rosacea
  • Use of acceptable methods of contraception
  • Are willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

  • Patient taking a topical or other therapy which may affect the patients rosacea
  • Actively managed glaucoma or active ocular infection or ocular systemic disease
  • Have hypersensitivity to lotilaner or any of the formulation components
  • Are currently enrolled in an investigational drug or device study
  • Are currently pregnant or lactating or planning to become pregnant during the study

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
lotilaner - high dose and low dose
Drug: lotilaner
lotilaner
Other: Control arm
Vehicle of lotilaner - high dose and low dose
Drug: Vehicle
Vehicle of lotilaner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events
Time Frame: Week 16
Number of patients with treatment related emergent adverse events (TEAEs)
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: Week 16
Measurement of intraocular pressure
Week 16
Visual acuity
Time Frame: Week 16
Measurement of visual acuity
Week 16

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telangiectasia
Time Frame: Week 16
Grading of telangiectasia
Week 16
Erythema
Time Frame: Week 16
Grading of erythema
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRS-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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