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Enrolling by Invitation

NCT Number: NCT07443202

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

To evaluate lotilaner treatment in patients with ocular rosacea.

Enrolling by Invitation

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Key information

Conditions

Ocular Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site, Houston, Texas, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lotilaner

Drug

lotilaner

Vehicle

Drug

Vehicle of lotilaner

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events

    Time frame: Week 16

    Number of patients with treatment related emergent adverse events (TEAEs)

Secondary outcomes

  1. Intraocular pressure

    Time frame: Week 16

    Measurement of intraocular pressure

  2. Visual acuity

    Time frame: Week 16

    Measurement of visual acuity

Other outcomes

  1. Telangiectasia

    Time frame: Week 16

    Grading of telangiectasia

  2. Erythema

    Time frame: Week 16

    Grading of erythema

Sponsors and collaborators

Lead sponsor

Tarsus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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