Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lotilaner, Vehicle.
- Who it may be relevant to
- Registry conditions: Ocular Rosacea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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
- Drug lotilaner
lotilaner - Drug Vehicle
Vehicle of lotilaner
Primary outcome measures
- Incidence of Treatment Emergent Adverse Events [Time frame: Week 16]
Secondary outcome measures (2)
- Intraocular pressure [Time frame: Week 16]
- Visual acuity [Time frame: Week 16]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Site — Houston
- Site — Lynchburg
Identifiers
NCT: NCT07443202 · TRS-030