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. (VISTA-1)

Aperta Biosciences, LLC

Status and phase: Enrolling; Phase 2

Conditions: Blepharitis

Treatments: Drug: Vehicle control for APT-001 topical ophthalmic ointment; Drug: APT-001 topical ophthalmic ointment (spinosad)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06720896

VISTA-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days

Treatment:

Drug: APT-001 topical ophthalmic ointment (spinosad)

Control

Placebo Comparator group

Description:

Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days

Treatment:

Drug: Vehicle control for APT-001 topical ophthalmic ointment