NCT07443202

Brief Summary

To evaluate lotilaner treatment in patients with ocular rosacea.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for phase_2

Timeline
20mo left

Started Dec 2025

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Dec 2025Dec 2027

Study Start

First participant enrolled

December 5, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 24, 2026

Last Update Submit

February 24, 2026

Conditions

Ocular Rosacea

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment Emergent Adverse Events

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

    Week 16

Secondary Outcomes (2)

  • Intraocular pressure

    Week 16

  • Visual acuity

    Week 16

Other Outcomes (2)

  • Telangiectasia

    Week 16

  • Erythema

    Week 16

Study Arms (2)

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

lotilanerDRUG

lotilaner

Treatment arm
VehicleDRUG

Vehicle of lotilaner

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site

Houston, Texas, 77027, United States

Location

Site

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

lotilaner

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

December 5, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)