Actively 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.
Led by Aperta Biosciences, LLC · Updated on 2026-05-05
100
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic blepharitis
- At least 6 years of age
- Eyelid collarette count with a minimum score of 2
- Willing and able to follow all instructions and attend all study visits
- Able to avoid prohibited medications during the study
- Able to provide informed consent or have a legal representative provide consent
You will not qualify if you...
- Women who are confirmed pregnant
- Currently using any medical therapy for the eye
- History of allergic reaction to spinosad or any component of the formulation
- Use of eyelid hygiene or other blepharitis treatments within 14 days before screening
- History of ocular surgery within the past 1 year
- Presence of other eye diseases that could affect study outcomes (such as corneal dystrophies, Salzmann's disease, severe dry eye, keratoconus, glaucoma filtering blebs)
- Use of investigational drugs, chronic glaucoma medications, or steroids
- Uncontrolled systemic disease
- Acute or chronic illnesses that could affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dr. Rudy Gutierrez Diaz Sede Central
Guatemala City, Guatemala
Actively Recruiting
2
EyeScan, Imágenes Diagnósticas Oculares, S. A.
Guatemala City, Guatemala
Actively Recruiting
Research Team
J
Josue Moran, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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