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NCT07904767
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Conditions: Blepharitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 15
Sponsor: Aperta Biosciences, LLC
Location: EyeScan, Imágenes Diagnósticas Oculares, S. A. Guatemala City
Summary
The purpose of this study is to establish the clinical efficacy of APT-001 topical therapy 1.8% in patients with blepharitis as compared to placebo, and to establish that the therapeutic is safe and generally well tolerated by patients.
Eligibility Criteria
Inclusion Criteria:
* Symptomatic blepharitis
* At least 18 years of age
* Eyelid collarette score of at least 2
* Demodex mite density of at least 1.5 mites per lash or higher
* Willing and able to follow all instructions and attend all study visit
* Able to avoid prohibited medication for the duration of the study
* Patients can willingly provide consent on the informed consent form
Exclusion Criteria:
* Women with confirmed pregnancies
* Utilizing any medical or surgical therapy for acute or subacute conditions of the eye
* History of allergic reaction to spinosad or any formulation component
* Patients using eyelid hygiene or other treatment(s) for blepharitis within 14 days of screening
* History of ocular surgery within the past 3 months
* Presence of other ocular diseases that may affect study outcomes
* Use of investigational drug, chronic glaucoma medications, or steroids
* Uncontrolled systemic disease
* Acute or chronic illness that would confound study results
Source: ClinicalTrials.gov (NCT07904767). StuddyBuddy aggregates publicly available trial information.