A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Pat… (NCT02102750) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients With Glaucoma or Ocular Hypertension
United States, United Kingdom17 participantsStarted 2014-06
Plain-language summary
The purpose of the study is to examine how preservative free tafluprost ophthalmic solution (0.0015%) is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.
Who can participate
Age range
1 Month – 17 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:
* Patient is a non-smoking male or female ≤ 17 years of age on the day of signing the informed consent. Infants must be at least 1 month of age
* A diagnosis of primary or secondary pediatric glaucoma or ocular hypertension in one or both eyes
* A history of IOP greater than or equal to 22 mmHg in at least one eye. Newly diagnosed patients may have this criterion fulfilled at the pre-study visit.
* Patient is currently prescribed ocular hypotensive medication and who according to investigator's judgement may discontinue the use at least day before the Day 1 visit, or patient is treatment-naïve (those who have never used used ocular hypotensive medication).
* Female patients of reproductive potential must demonstrate a negative pregnancy test at the pre-study visit
* Patient is judged to be in good health, other than having glaucoma or ocular hypertension, based on medical history, physical examination, vital signs measurements, and laboratory safety tests performed at the pre-study visit and/or prior to administration of the initial dose of study drug
* Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the pre-study visit
* Parent/legal guardian and/or patient have/has provided a written informed consent (according to existing local regulations) and patient assent has been given as applicable.
* The patient and parent/guardian should agree to comply with study restrictions, treatment plan, procedures and keep schedu…
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.