Not Signed In -
Evening Primrose |
Fever Plant; Oenothera biennis; Oenothera species; OEP; Sun Drop |
Clinical Trial: A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma
This study is currently recruiting patients.
Verified by Pfizer August 2005
|
Purpose
To demonstrate the statistical non inferiority of the combination of latanopost 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 | Intervention | Phase |
|---|---|---|
| Glaucoma, Open Angle Ocular Hypertension | Drug: Xalacom Drug: Cosopt | Phase IV |
MedlinePlus related topics: Eye Diseases; Glaucoma
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.
Further Study Details:
Primary Outcomes: The mean IOP measurements obtained in the study eye at each time point
Expected Total Enrollment: 238
Expected Total Enrollment: 238
Study start: July 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00140049
Pfizer CT.gov Call Center 1-800-718-1021
Germany
Pfizer Investigational Site, Starnberg, 82319, Germany; Recruiting
Pfizer Investigational Site, Regenstauf, 93128, Germany; Recruiting
Pfizer Investigational Site, Schorndorf, 73614, Germany; Recruiting
Pfizer Investigational Site, Darmstadt, 64297, Germany; Recruiting
Pfizer Investigational Site, Landau / Pfalz, 76829, Germany; Recruiting
Study chairs or principal investigators
Pfizer Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A6641038
Last Updated: August 30, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00140049
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: August 30, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00140049
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06
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