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.

Launched by APERTA BIOSCIENCES, LLC · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called APT-001, which is a topical therapy, for people with blepharitis, a condition that causes inflammation and discomfort of the eyelids. The study aims to see how effective this treatment is compared to a placebo (a treatment that doesn't have any active ingredients) and to ensure that it is safe and well-tolerated by patients.

To participate in the study, individuals need to be at least 6 years old and have symptoms of blepharitis. They should also have a specific score related to eyelid symptoms and be willing to attend all study visits and follow instructions. However, some people may not be eligible, such as those who are pregnant, have certain eye conditions, or are currently using other eye treatments. Participants in this trial will help researchers understand if APT-001 can provide relief for blepharitis and contribute to the development of better treatment options for this condition.

Gender

ALL

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.