Status:

RECRUITING

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.

Lead Sponsor:

Aperta Biosciences, LLC

Conditions:

Blepharitis

Eligibility:

All Genders

6+ years

Phase:

PHASE2

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 i...

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 ...

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.

Key Trial Info

Start Date :

November 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06720896

Start Date

November 1 2025

End Date

April 1 2026

Last Update

December 16 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Dr. Rudy Gutierrez Diaz Sede Central

Guatemala City, Guatemala

2

EyeScan, Imágenes Diagnósticas Oculares, S. A.

Guatemala City, Guatemala