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)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Blepharitis
• Intervention / Treatment: Drug: APT-001 topical ophthalmic ointment (spinosad); Drug: Vehicle control for APT-001 topical ophthalmic ointment

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days	Drug: APT-001 topical ophthalmic ointment (spinosad); APT-001 topical ophthalmic ointment, administered once daily
Placebo Comparator: Control; Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days	Drug: Vehicle control for APT-001 topical ophthalmic ointment; Vehicle control for APT-001 topical ophthalmic ointment, administered once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collarette Cure	Eyelid collarette count score 0	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall reduction in combined eyelid collarette and erythema scores	Overall reduction in combined eyelid collarette and erythema scores	From enrollment to the end of treatment at 6 weeks
Erythema Cure rate	Erythema Cure rate	From enrollment to the end of treatment at 6 weeks
Combined Cure rate	Combined Cure rate	From enrollment to the end of treatment at 6 weeks
Demodex mite density	Demodex mite density	From enrollment to the end of treatment at 6 weeks
Time to a Combined Cure.	Time to a Combined Cure	From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: Aperta Biosciences, LLC
• Investigators: Study Director: Josue Moran, Ph.D., Aperta Biosciences, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Blepharitis
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis; spinosad
• Other Study ID Numbers: VISTA-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes