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.

Phase 2

Not yet recruiting

• Conditions: Blepharitis
• Interventions: Drug: APT-001 topical ophthalmic ointment (spinosad); Drug: Vehicle control for APT-001 topical ophthalmic ointment

• Registration Number: NCT06720896
• Lead Sponsor: Aperta Biosciences, LLC

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.

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 Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Study Start: 2025-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	APT-001 topical ophthalmic ointment (spinosad)	APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
Control	Vehicle control for APT-001 topical ophthalmic ointment	Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days

Primary Outcome Measures

Name	Time	Method
Collarette Cure	From enrollment to the end of treatment at 6 weeks	Eyelid collarette count score 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr. Rudy Gutierrez Diaz Sede Central; 🇬🇹 Guatemala City, Guatemala