Safety And Efficacy Of Xalatan Delivered Using Either A Conventional Dropper Bottle or A Delivery Device
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00283764
Collaborator
(none)
0
Study Details
Study Description
Brief Summary
Compare the antihypertensive efficacy of two methods for instilling Xalatan eyedrops
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
A Phase 3, 12-Week, Parallel-Design Study Comparing The Safety, Efficacy, and Ease Of Use Of Xalatan When Self-Administered By Subjects With Open-Angle Glaucoma Or Ocular Hypertension Using Either A Conventional Dropper Bottle Or A Forced-Flow Delivery Device
Outcome Measures
Primary Outcome Measures
- Intra-ocular pressure (IOP) level in the study eye. []
Secondary Outcome Measures
- Successful eyedrop self-deliveries []
- Ease of eyedrop administration []
- Change in safety assessments throughout the study period []
- Subject preference for the method of drop delivery []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes
Exclusion Criteria:
- History of closed/barely open anterior chamber angle or a history of angle closure
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00283764
Other Study ID Numbers:
- A6111086
First Posted:
Jan 30, 2006
Last Update Posted:
Feb 2, 2021
Last Verified:
Mar 1, 2015
Additional relevant MeSH terms: