A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Saf… (NCT06720896) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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.
Guatemala100 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collarette Cure
Timeframe: From enrollment to the end of treatment at 6 weeks