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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1
Dr. Rudy Gutierrez Diaz Sede Central
Guatemala City, Guatemala
2
EyeScan, Imágenes Diagnósticas Oculares, S. A.
Guatemala City, Guatemala