APT-001 (Spinosad 1.8%) eyelid ointment for blepharitis

Vision and Inflammation Study Testing Anti-acarid Therapeutics (VISTA-1): 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.

This randomized, double-blind test will see if APT-001 (spinosad 1.8%) eyelid ointment clears collarettes and is safe in people aged 6 and older with symptomatic blepharitis compared with an inactive vehicle.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 6 Years and up
• Sex: All
• Sponsor: Aperta Biosciences, LLC (Industry-sponsored)
• Locations: 2 sites (Guatemala City and 1 other locations)
• Trial ID: NCT06720896 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, controlled, double-blind multicenter trial compares APT-001 1.8% topical ophthalmic ointment to its vehicle control over a 43-day treatment period. The primary efficacy endpoint is cure based on eyelid collarette counts, and safety will be monitored by recording treatment-related adverse events. Eligible participants are age 6 and older with symptomatic blepharitis and a minimum collarette score, and must avoid other eyelid treatments during the study. The trial is being conducted at clinical sites in Guatemala City under sponsorship of Aperta Biosciences.

Who should consider this trial

Good fit: Ideal candidates are people aged 6 or older with symptomatic blepharitis and a minimum collarette count (score ≥2) who can attend visits and avoid other prohibited eyelid therapies.

Not a fit: Patients who are pregnant, allergic to spinosad, using current ocular therapies, have recent ocular surgery, significant other ocular disease, or uncontrolled systemic illness are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, APT-001 could offer a well-tolerated topical option that reduces eyelid collarettes and improves blepharitis symptoms.

How similar studies have performed: Topical spinosad formulations have shown promise in smaller or open-label reports for Demodex-associated blepharitis, but randomized phase 2 data are limited.

Eligibility criteria

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.

Where this trial is running

Guatemala City and 1 other locations

• Dr. Rudy Gutierrez Diaz Sede Central — Guatemala City, Guatemala (Recruiting)
• EyeScan, Imágenes Diagnósticas Oculares, S. A. — Guatemala City, Guatemala (Recruiting)

Study contacts

• Study coordinator: Josue Moran, Ph.D.

Conditions Blepharitis