Overview
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.
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.
Eligibility
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.