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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00856622 |
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.
Condition | Intervention | Phase |
---|---|---|
Ocular Hypertension Glaucoma Open-Angle Glaucoma |
Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5% Drug: timolol 0.5% ophthalmic solution Drug: latanoprost 0.005% ophthalmic solution |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 6-Month, Randomized, Double-Masked Comparison Of Fixed Combination Of Latanoprost And Timolol With The Individual Components, Continuing Into A 6-Month Open Label Safety Study Of Fixed Combination In Patients With Glaucoma Or Ocular Hypertension. |
Enrollment: | 436 |
Study Start Date: | August 1997 |
Study Completion Date: | June 1999 |
Primary Completion Date: | June 1999 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Fixed combination of latanoprost 0.005% and timolol 0.5%: Experimental |
Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%
one drop in the morning and placebo in the evening
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timolol 0.5% ophthalmic solution: Active Comparator
one drop in the morning and evening
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Drug: timolol 0.5% ophthalmic solution
one drop in the morning and evening
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latanoprost 0.005% ophthalmic solution: Active Comparator
placebo in the morning and latanoprost .005% in the evening
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Drug: latanoprost 0.005% ophthalmic solution
placebo in the morning and latanoprost .005% in the evening
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Pfizer Investigational Site | |
Aalen, Germany | |
Pfizer Investigational Site | |
Hannover, Germany | |
Pfizer Investigational Site | |
Sulzbach, Germany, 66280 | |
Pfizer Investigational Site | |
Gummersbach, Germany, 51643 | |
Pfizer Investigational Site | |
Mainz, Germany, 55131 | |
Pfizer Investigational Site | |
Ahaus, Germany, 48683 | |
Pfizer Investigational Site | |
Koblenz, Germany, 56068 | |
Pfizer Investigational Site | |
Parsberg, Germany, 92331 | |
Pfizer Investigational Site | |
Leonberg, Germany, 71229 | |
Pfizer Investigational Site | |
Mainz, Germany, 55116 | |
Pfizer Investigational Site | |
Trier, Germany, 54290 | |
Pfizer Investigational Site | |
Osnabrueck, Germany, 49076 | |
Pfizer Investigational Site | |
Berlin, Germany, 13088 | |
Pfizer Investigational Site | |
Muenchen, Germany, 80336 | |
Pfizer Investigational Site | |
Freising, Germany, 85354 | |
Pfizer Investigational Site | |
Muenchen, Germany, 81925 | |
Pfizer Investigational Site | |
Essen, Germany, 45147 | |
Pfizer Investigational Site | |
Eitorf, Germany, 53783 | |
Pfizer Investigational Site | |
Leverkusen, Germany, 51373 | |
Pfizer Investigational Site | |
Fulda, Germany | |
Pfizer Investigational Site | |
Bad Abbach, Germany, 93077 | |
Pfizer Investigational Site | |
Weiden, Germany, 92637 | |
Pfizer Investigational Site | |
Dillingen, Germany, 89407 | |
Pfizer Investigational Site | |
Mainz, Germany, 55124 | |
Pfizer Investigational Site | |
Mülheim, Germany, 45481 | |
Pfizer Investigational Site | |
Iserlohn, Germany, 58638 | |
Pfizer Investigational Site | |
Hirschaid, Germany, 96114 | |
Pfizer Investigational Site | |
Erlangen, Germany, 91052 | |
Pfizer Investigational Site | |
Aschaffenburg, Germany, 63739 | |
Pfizer Investigational Site | |
Coesfeld, Germany, 48653 | |
Pfizer Investigational Site | |
Siegburg, Germany, 53721 | |
Pfizer Investigational Site | |
Offenbach, Germany, 63065 | |
Pfizer Investigational Site | |
Freiburg, Germany, 79106 | |
Pfizer Investigational Site | |
Greifswald, Germany, 17489 | |
Pfizer Investigational Site | |
Alzey, Germany, 55232 | |
Pfizer Investigational Site | |
Aachen, Germany | |
Pfizer Investigational Site | |
Münster, Germany, 48165 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | 96TIPG004, A6641005 |
Study First Received: | March 2, 2009 |
Last Updated: | June 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00856622 History of Changes |
Health Authority: | United States: Food and Drug Administration |
open-angle glaucoma
ocular hypertension
glaucoma |
Neurotransmitter Agents Adrenergic Agents Eye Diseases Vascular Diseases Cardiovascular Agents Antihypertensive Agents Latanoprost Glaucoma |
Glaucoma, Open-Angle Adrenergic beta-Antagonists Adrenergic Antagonists Timolol Anti-Arrhythmia Agents Ocular Hypertension Hypertension |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Eye Diseases Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents Antihypertensive Agents Latanoprost Pharmacologic Actions |
Glaucoma Therapeutic Uses Glaucoma, Open-Angle Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents Timolol Hypertension Ocular Hypertension |