Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-28 @ 8:16 PM
Study NCT ID:
NCT02102750
Status:
COMPLETED
Last Update Posted:
2017-10-10
First Post:
2014-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients With Glaucoma or Ocular Hypertension
Sponsor:
Santen Oy
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-004302-26 | EUDRACT_NUMBER | None | View |