Study of Lotilaner Ophthalmic Gel in Patients With Ocular... | NCT07443202

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

NCT07443202

Sponsor

Tarsus Pharmaceuticals, Inc.

Status

Enrolling by invitation

Last Update Posted

Mar 2, 2026Actual

Enrollment

155Estimated

Phase

Phase 2

Conditions

Ocular Rosacea

Interventions

lotilaner
Vehicle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Feb 24, 2026

First Submission Date that Met QC Criteria

Feb 24, 2026

First Posted Date

Mar 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Mar 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate lotilaner treatment in patients with ocular rosacea.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

155Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental	lotilaner - high dose and low dose	Drug: lotilaner
Control arm	Other	Vehicle of lotilaner - high dose and low dose	Drug: Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lotilaner	Drug	lotilaner	Treatment arm
Vehicle

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site		Houston	Texas	77027	United States
Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012393	Rosacea

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000711088	lotilaner

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided