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.

NCT06720896 | Recruiting Phase 2

• 1 other identifier: VISTA-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Blepharitis

Keywords

Blepharitis

Outcome Measures

Primary Outcomes (1)

• Collarette Cure

  Eyelid collarette count score 0

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (5)

• Overall reduction in combined eyelid collarette and erythema scores

  From enrollment to the end of treatment at 6 weeks

• Erythema Cure rate

  From enrollment to the end of treatment at 6 weeks

• Combined Cure rate

  From enrollment to the end of treatment at 6 weeks

• Demodex mite density

  From enrollment to the end of treatment at 6 weeks

• Time to a Combined Cure.

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Drug: APT-001 topical ophthalmic ointment (spinosad)

Control

PLACEBO COMPARATOR

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

Drug: Vehicle control for APT-001 topical ophthalmic ointment

Interventions

APT-001 topical ophthalmic ointment (spinosad) DRUG

APT-001 topical ophthalmic ointment, administered once daily

Active

Vehicle control for APT-001 topical ophthalmic ointment DRUG

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

Control

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aperta Biosciences, LLC: lead

Study Sites (2)

Dr. Rudy Gutierrez Diaz Sede Central

Guatemala City, Guatemala

RECRUITING

EyeScan, Imágenes Diagnósticas Oculares, S. A.

Guatemala City, Guatemala

RECRUITING

MeSH Terms

Conditions

Blepharitis

Interventions

spinosad

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Josue Moran, Ph.D.

  Aperta Biosciences, LLC

  STUDY DIRECTOR

Central Study Contacts

Josue Moran, Ph.D.

CONTACT

512-270-3960; vista@apertabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GU (2)