Blepharitis
Conditions
Keywords
Blepharitis
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.
Interventions
DRUGAPT-001 topical ophthalmic ointment (spinosad)
APT-001 topical ophthalmic ointment, administered once daily
DRUGVehicle control for APT-001 topical ophthalmic ointment
Vehicle control for APT-001 topical ophthalmic ointment, administered once daily
Sponsors
Aperta Biosciences, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collarette Cure | From enrollment to the end of treatment at 6 weeks | Eyelid collarette count score 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Guatemala
Contacts
STUDY_DIRECTORJosue Moran, Ph.D.
Aperta Biosciences, LLC
Outcome results
None listed