A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00140049
Collaborator
(none)
238
25
12
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Study Details
Study Description
Brief Summary
To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
A 12-Week Randomized, Evaluator-Masked, Parallel-Group, Multinational, Multi-Center Study Comparing The Efficacy And Safety Of The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt) In Patients With Open-Angle Glaucoma Or Ocular Hypertension.
Study Start Date
:
Jul 1, 2005
Actual Study Completion Date
:
Jul 1, 2006
Outcome Measures
Primary Outcome Measures
- The mean IOP measurements obtained in the study eye at each time point []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Caen | France | 14033 | |
| 2 | Pfizer Investigational Site | Clermont-ferrand | France | 63003 | |
| 3 | Pfizer Investigational Site | Lyon | France | 69437 | |
| 4 | Pfizer Investigational Site | Marseille Cedex 05 | France | 13385 | |
| 5 | Pfizer Investigational Site | Saint Herblain | France | 44800 | |
| 6 | Pfizer Investigational Site | Darmstadt | Germany | 64283 | |
| 7 | Pfizer Investigational Site | Darmstadt | Germany | 64297 | |
| 8 | Pfizer Investigational Site | Landau / Pfalz | Germany | 76829 | |
| 9 | Pfizer Investigational Site | Regenstauf | Germany | 93128 | |
| 10 | Pfizer Investigational Site | Schorndorf | Germany | 73614 | |
| 11 | Pfizer Investigational Site | Starnberg | Germany | 82319 | |
| 12 | Pfizer Investigational Site | Heraklion | Crete | Greece | 71110 |
| 13 | Pfizer Investigational Site | Thessaloniki | Macedonia | Greece | 546 36 |
| 14 | Pfizer Investigational Site | Alexandroupoli | Greece | 68100 | |
| 15 | Pfizer Investigational Site | Larisa | Greece | 41110 | |
| 16 | Pfizer Investigational Site | Chieti | Italy | 66013 | |
| 17 | Pfizer Investigational Site | Foggia | Italy | 71100 | |
| 18 | Pfizer Investigational Site | Genova | Italy | 16132 | |
| 19 | Pfizer Investigational Site | Milano | Italy | 20132 | |
| 20 | Pfizer Investigational Site | Monza (MI) | Italy | 20052 | |
| 21 | Pfizer Investigational Site | Pisa | Italy | 56126 | |
| 22 | Pfizer Investigational Site | Malmo | Sweden | 205 02 | |
| 23 | Pfizer Investigational Site | Molndal | Sweden | 431 80 | |
| 24 | Pfizer Investigational Site | Sundsvall | Sweden | 851 86 | |
| 25 | Pfizer Investigational Site | örebro | Sweden | 703 61 |
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:
NCT00140049
Other Study ID Numbers:
- A6641038
First Posted:
Aug 31, 2005
Last Update Posted:
Feb 18, 2021
Last Verified:
Nov 1, 2007