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

NCT02102750 Phase 1 COMPLETED

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.

Details

Lead sponsor	Santen Oy
Phase	Phase 1
Status	COMPLETED
Enrolment	17
Start date	2014-06
Completion	2017-07-03

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

• Preservative free tafluprost opthalmic solution

Primary outcomes

• Plasma concentration of tafluprost acid. — 8 days +/- 1 day window

Countries

United States, United Kingdom