Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-31 @ 11:46 PM
Study NCT ID:
NCT03131167
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma
Sponsor:
Shire
Organization:
Study Overview
Official Title:
A Randomized, Double-masked, Placebo-controlled Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Daily and Multiple Daily Ascending Doses of SHP639 Topical Ophthalmic Solution in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma (POAG)
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the investigational SHP639 eye drops will be evaluated in participants with high eye pressure or primary open-angle glaucoma.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: