|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00277498 |
|
Date of registration:
|
13/01/2006 |
|
Primary sponsor: |
|
|
Public title:
|
A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma
|
|
Scientific title:
|
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension In The United States. |
|
Date of first enrolment:
|
December 2005 |
|
Target sample size:
|
528 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00277498 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening
Exclusion Criteria:
- Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
- History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Ocular Hypertension
|
|
Open Angle Glaucoma
|
|
Intervention(s)
|
|
Drug: Timolol
|
|
Drug: Xalacom
|
|
Drug: Xalatan
|
|
Primary Outcome(s)
|
|
The mean IOP measurements obtained in the study eye at each time point.
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|