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.

Last updated: May 17, 2026
Sponsor: Aperta Biosciences, LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Blepharitis

Treatment

APT-001 topical ophthalmic ointment (spinosad)

Vehicle control for APT-001 topical ophthalmic ointment

Clinical Study ID

NCT06720896
VISTA-1
  • Ages > 6
  • All Genders

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

Eligibility Criteria

Inclusion

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 representativeprovide consent on the informed consent (IC) Form.

Exclusion

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 daysof screening.

  • History of ocular surgery within the past 1 year.

  • Presence of other ocular diseases that may affect study outcomes (CornealDystrophies, Salzmanns disease, Severe dry eye, Keratoconus, Glaucoma filteringblebs).

  • Use of investigational drug, chronic glaucoma medications, steroid.

  • Uncontrolled systemic disease.

  • Acute or chronic illness that would confound study results.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: APT-001 topical ophthalmic ointment (spinosad)
Phase: 2
Study Start date:
November 01, 2025
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Dr. Rudy Gutierrez Diaz Sede Central

    Guatemala City,
    Guatemala

    Site Not Available

  • EyeScan, Imágenes Diagnósticas Oculares, S. A.

    Guatemala City,
    Guatemala

    Site Not Available

  • Dr. Rudy Gutierrez Diaz Sede Central

    Guatemala City 3598132,
    Guatemala

    Site Not Available

  • EyeScan, Imágenes Diagnósticas Oculares, S. A.

    Guatemala City 3598132,
    Guatemala

    Active - Recruiting

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