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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07904767). StuddyBuddy aggregates publicly available trial information.