Ocular Rosacea
Conditions
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.
Interventions
DRUGlotilaner
lotilaner
DRUGVehicle
Vehicle of lotilaner
Sponsors
Tarsus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | Week 16 | Number of patients with treatment related emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | Week 16 | Measurement of intraocular pressure |
| Visual acuity | Week 16 | Measurement of visual acuity |
Countries
United States
Outcome results
None listed