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| ID | Type | Description | Link |
|---|---|---|---|
| A6641005 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed combination of latanoprost 0.005% and timolol 0.5% | Experimental |
| |
| timolol 0.5% ophthalmic solution | Active Comparator | one drop in the morning and evening |
|
| latanoprost 0.005% ophthalmic solution | Active Comparator | placebo in the morning and latanoprost .005% in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i. Fixed combination of latanoprost 0.005% and timolol 0.5% | Drug | one drop in the morning and placebo in the evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26 | 6 Months | |
| To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Aachen | Germany | ||||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| timolol 0.5% ophthalmic solution | Drug | one drop in the morning and evening |
|
|
| latanoprost 0.005% ophthalmic solution | Drug | placebo in the morning and latanoprost .005% in the evening |
|
|
| To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups | 6 Months |
| To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26 | 6 Months |
| To describe the IOP development from baseline to Week 26 for all treatment groups | 6 Months |
| To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination | 6 Months |
| To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 | 6 Months |
| To follow the safety variables throughout the study periods. | 6 Months |
| Aalen |
| Germany |
| Pfizer Investigational Site | Ahaus | 48683 | Germany |
| Pfizer Investigational Site | Alzey | 55232 | Germany |
| Pfizer Investigational Site | Aschaffenburg | 63739 | Germany |
| Pfizer Investigational Site | Bad Abbach | 93077 | Germany |
| Pfizer Investigational Site | Berlin | 13088 | Germany |
| Pfizer Investigational Site | Coesfeld | 48653 | Germany |
| Pfizer Investigational Site | Dillingen | 89407 | Germany |
| Pfizer Investigational Site | Eitorf | 53783 | Germany |
| Pfizer Investigational Site | Erlangen | 91052 | Germany |
| Pfizer Investigational Site | Essen | 45147 | Germany |
| Pfizer Investigational Site | Freiburg im Breisgau | 79106 | Germany |
| Pfizer Investigational Site | Freising | 85354 | Germany |
| Pfizer Investigational Site | Fulda | Germany |
| Pfizer Investigational Site | Greifswald | 17489 | Germany |
| Pfizer Investigational Site | Gummersbach | 51643 | Germany |
| Pfizer Investigational Site | Hanover | Germany |
| Pfizer Investigational Site | Hirschaid | 96114 | Germany |
| Pfizer Investigational Site | Iserlohn | 58638 | Germany |
| Pfizer Investigational Site | Koblenz | 56068 | Germany |
| Pfizer Investigational Site | Leonberg | 71229 | Germany |
| Pfizer Investigational Site | Leverkusen | 51373 | Germany |
| Pfizer Investigational Site | Mainz | 55116 | Germany |
| Pfizer Investigational Site | Mainz | 55124 | Germany |
| Pfizer Investigational Site | Mainz | 55131 | Germany |
| Pfizer Investigational Site | Mülheim | 45481 | Germany |
| Pfizer Investigational Site | München | 80336 | Germany |
| Pfizer Investigational Site | München | 81925 | Germany |
| Pfizer Investigational Site | Münster | 48165 | Germany |
| Pfizer Investigational Site | Offenbach | 63065 | Germany |
| Pfizer Investigational Site | Osnabrück | 49076 | Germany |
| Pfizer Investigational Site | Parsberg | 92331 | Germany |
| Pfizer Investigational Site | Siegburg | 53721 | Germany |
| Pfizer Investigational Site | Sulzbach | 66280 | Germany |
| Pfizer Investigational Site | Trier | 54290 | Germany |
| Pfizer Investigational Site | Weiden | 92637 | Germany |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C571753 | Xalacom |
| D013999 | Timolol |
| D009883 | Ophthalmic Solutions |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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