A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients.

Santen Oy0 sites18 target enrollmentJanuary 26, 2016

Overview

No summary available.

Registry

who.int

Start Date

January 26, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Patient is a non\-smoking male or female \= 17 years of age on the day of signing the informed consent with the first day of study drug dosing to occur prior to the 18th birthday. Infants less than 12 months old must be of \= 36 weeks gestational age and at least 1 month of age.
•2\. A diagnosis of primary or secondary paediatric glaucoma or ocular hypertension in one or both eyes.
•3\. A history of intraocular pressure (IOP) greater than or equal to 22 mmHg in at least one eye. Newly diagnosed patients may have this criterion fulfilled at the prestudy visit.
•4\. Patient is currently prescribed ocular hypotensive medication or patient is treatmentnaïve.
•5\. Female patients of reproductive potential must demonstrate a negative pregnancy test at the prestudy visit.
•6\. 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 .
•7\. Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy visit.
•8\. Parent/legal guardian and/or patient have/has provided a written informed consent and patient assent has been given as applicable.
•9\. The patient and parent/guardian should agree to comply with study restrictions, treatment plan, procedures and keep scheduled clinic visits.
•Are the trial subjects under 18? yes

•1\. Patient currently wears continuous wear contact lenses (use of daily wear contact lenses during the study is permitted).
•2\. Onesighted or monocular patients, including patients who cannot be dosed in both eyes for any reason.
•3\. History of goniotomy or trabeculotomy within 1 month of prestudy visit or history of cataract surgery, laser surgery, filtration surgery, implant surgery or cyclodestructive surgery within 3 months prior to prestudy visit in one or both eyes.
•4\. Patient has a history or evidence of significant ocular trauma within 3 months of prestudy visit.
•5\. Patient has a history or evidence of recent ocular inflammation and/or infection within 1 month of prestudy visit.
•6\. Patient has chronic conjunctivitis, chronic keratitis or lacrimal deficiency.
•7\. Patient is pregnant, breastfeeding, expecting to conceive within the projected duration of the study.
•8\. Patient has had major (nonocular) surgery, loss of \> 5 cc/kg of blood within 4 weeks of the prestudy visit.
•9\. Any other ocular, systemic or psychiatric disease/condition or laboratory abnormality that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient’s participation in the study as judged by the investigator.
•10\. History of febrile illness within 5 days prior to start of study treatment.