A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis.

Phase 2Active Not RecruitingNCT06720896

Aperta Biosciences, LLC100 enrolled

Overview

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 its vehicle control, and to establish that the therapeutic is safe and generally well tolerated by patients.

This Phase 2 study is a randomized, controlled, double-blind trial to compare the safety and efficacy of APT-001 1.8% to vehicle control for the treatment of blepharitis. The primary objective of the study is to compare the safety and efficacy of APT-001 compared to its vehicle from Day 1 to Day 43 in patients with blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Blepharitis

Interventions

APT-001 topical ophthalmic ointment (spinosad)DRUG

APT-001 topical ophthalmic ointment, administered once daily

Vehicle control for APT-001 topical ophthalmic ointmentDRUG

Vehicle control for APT-001 topical ophthalmic ointment, administered once daily

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic blepharitis. * At least 6 years of age. * Eyelid collarette count (minimum score 2). * Willing and able to follow all instructions and attend all study visits. * Able to avoid prohibited medication for the duration of the study. * Patients can willingly provide consent or have a legal authorized representative provide consent on the informed consent (IC) Form. Exclusion Criteria: * Women with confirmed pregnancies. * Utilizing any current medical therapy for 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 1 year. * Presence of other ocular diseases that may affect study outcomes (Corneal Dystrophies, Salzmanns disease, Severe dry eye, Keratoconus, Glaucoma filtering blebs). * Use of investigational drug, chronic glaucoma medications, steroid. * Uncontrolled systemic disease. * Acute or chronic illness that would confound study results.

Locations (2)

Dr. Rudy Gutierrez Diaz Sede Central

Guatemala City, Guatemala

EyeScan, Imágenes Diagnósticas Oculares, S. A.

Guatemala City, Guatemala