Ocular RosaceaPhase 2NCT07443202
Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)
A Phase 2 study testing lotilaner in people with Ocular Rosacea, run by Tarsus Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
To evaluate lotilaner treatment in patients with ocular rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Rosacea
- What is being tested?
- lotilaner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Site
Houston, Texas, 77027
Site
Lynchburg, Virginia, 24502
About this study
Official 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)
To evaluate lotilaner treatment in patients with ocular rosacea.
Read the detailed description
To evaluate safety of lotilaner compared to vehicle control in the treatment of ocular rosacea.
- Conditions
- Ocular Rosacea
- Being tested
- lotilaner, Vehicle
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lotilanerDrug
lotilaner
VehicleDrug
Vehicle of lotilaner
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | lotilaner - high dose and low dose Receives: Drug: lotilaner |
| Control arm | Other | Vehicle of lotilaner - high dose and low dose Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
Number of patients with treatment related emergent adverse events (TEAEs)
Measured: Week 16
Secondary outcomes (2)
Intraocular pressure
Measurement of intraocular pressure
Measured: Week 16
Visual acuity
Measurement of visual acuity
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start5 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443202
- Sponsor's protocol ID
- TRS-030
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07443202
- Acronym / sponsor ID
- TRS-030
- Conditions
- Ocular Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: lotilanerlotilaner - high dose and low dose |
| Control arm | Other | Drug: VehicleVehicle of lotilaner - high dose and low dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lotilanerlotilaner | Drug | Treatment arm |
| VehicleVehicle of lotilaner | Drug | Control arm |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: Week 16
Number of patients with treatment related emergent adverse events (TEAEs)
2 secondary outcomes
Intraocular pressure
Time frame: Week 16
Visual acuity
Time frame: Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lotilaner in people with Ocular Rosacea, run by Tarsus Pharmaceuticals, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.