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To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Procedure | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSS questionnaire | Procedure | D0, D30 and D84 |
| |
| IOP |
| Measure | Description | Time Frame |
|---|---|---|
| A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population. | after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and relative IOP change after 4 and 12 weeks of treatment | week 4 and 12 | |
| Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment, | week 12 |
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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 | Agen | 47000 | France | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20346127 | Derived | Sellem E, Rouland JF, Baudouin C, Bron A, Denis P, Nordmann JP, Renard JP. Predictors of additional intraocular pressure reduction in patients changed to latanoprost/timolol fixed combination. BMC Ophthalmol. 2010 Mar 26;10:10. doi: 10.1186/1471-2415-10-10. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Procedure |
D0, D30 and D84 |
|
| LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION | Drug | in the evening during 84 days |
|
|
| Visual acuity | Procedure | D0 and D84 |
|
| Amboise |
| 37400 |
| France |
| Pfizer Investigational Site | Amiens | 80000 | France |
| Pfizer Investigational Site | Andrésy | 78570 | France |
| Pfizer Investigational Site | Asnières-sur-Seine | 92600 | France |
| Pfizer Investigational Site | Aubière | 63170 | France |
| Pfizer Investigational Site | Aurillac | 15000 | France |
| Pfizer Investigational Site | Belfort | 90000 | France |
| Pfizer Investigational Site | Besançon | 25000 | France |
| Pfizer Investigational Site | Béziers | 34500 | France |
| Pfizer Investigational Site | Bordeaux | 33000 | France |
| Pfizer Investigational Site | Bourg-en-Bresse | 01000 | France |
| Pfizer Investigational Site | Caen | 14000 | France |
| Pfizer Investigational Site | Cannes | 06400 | France |
| Pfizer Investigational Site | Castelsarrasin | 82100 | France |
| Pfizer Investigational Site | Chalon-sur-Saône | 71100 | France |
| Pfizer Investigational Site | Chamalieres-Royat | 63400 | France |
| Pfizer Investigational Site | Chambéry | 73000 | France |
| Pfizer Investigational Site | Chartres | 28000 | France |
| Pfizer Investigational Site | Chassieu | France |
| Pfizer Investigational Site | Châlons-en-Champagne | 51000 | France |
| Pfizer Investigational Site | Château-Renault | 37110 | France |
| Pfizer Investigational Site | Châteaudun | 28200 | France |
| Pfizer Investigational Site | Clamart | 92140 | France |
| Pfizer Investigational Site | Clermont-Ferrand | 63000 | France |
| Pfizer Investigational Site | Clermont-Ferrand | 63100 | France |
| Pfizer Investigational Site | Colmar | 68000 | France |
| Pfizer Investigational Site | Coulommiers | 77120 | France |
| Pfizer Investigational Site | Dax | 40100 | France |
| Pfizer Investigational Site | Étampes | 91150 | France |
| Pfizer Investigational Site | Figeac | 46100 | France |
| Pfizer Investigational Site | Fréjus | 83600 | France |
| Pfizer Investigational Site | Goussainville | 95190 | France |
| Pfizer Investigational Site | Haguenau | 67500 | France |
| Pfizer Investigational Site | Hyères | 83400 | France |
| Pfizer Investigational Site | Issy-les-Moulineaux | 92130 | France |
| Pfizer Investigational Site | Ivry-sur-Seine | 94200 | France |
| Pfizer Investigational Site | Jarny | 54800 | France |
| Pfizer Investigational Site | La Flèche | 72200 | France |
| Pfizer Investigational Site | Langon | 33210 | France |
| Pfizer Investigational Site | Lannion | 22300 | France |
| Pfizer Investigational Site | Le Mans | 72000 | France |
| Pfizer Investigational Site | Le Quesnoy | 59530 | France |
| Pfizer Investigational Site | Les Clayes-sous-Bois | 78340 | France |
| Pfizer Investigational Site | Les Lilas | 93260 | France |
| Pfizer Investigational Site | Lille | 59037 | France |
| Pfizer Investigational Site | Limoges | 87100 | France |
| Pfizer Investigational Site | Luxeuil-les-Bains | 70300 | France |
| Pfizer Investigational Site | Lyon | 69001 | France |
| Pfizer Investigational Site | Lyon | 69006 | France |
| Pfizer Investigational Site | Lyon | 69009 | France |
| Pfizer Investigational Site | Marseille | 13004 | France |
| Pfizer Investigational Site | Marseille | 13005 | France |
| Pfizer Investigational Site | Marseille | 13008 | France |
| Pfizer Investigational Site | Marseille | 13009 | France |
| Pfizer Investigational Site | Meaux | 77100 | France |
| Pfizer Investigational Site | Meudon | 921090 | France |
| Pfizer Investigational Site | Meyzieu | 69330 | France |
| Pfizer Investigational Site | Montargis | 45200 | France |
| Pfizer Investigational Site | Montbéliard | 25200 | France |
| Pfizer Investigational Site | Montigny-le-Bretonneux | 78180 | France |
| Pfizer Investigational Site | Moulins | 03000 | France |
| Pfizer Investigational Site | Mulhouse | 68100 | France |
| Pfizer Investigational Site | Nantes | 44000 | France |
| Pfizer Investigational Site | Nemours | 77140 | France |
| Pfizer Investigational Site | Nice | 06000 | France |
| Pfizer Investigational Site | Nœux-les-Mines | 62290 | France |
| Pfizer Investigational Site | Orléans | 08025 | France |
| Pfizer Investigational Site | Orsay | 91400 | France |
| Pfizer Investigational Site | Pantin | 93500 | France |
| Pfizer Investigational Site | Paris | 75007 | France |
| Pfizer Investigational Site | Paris | 75008 | France |
| Pfizer Investigational Site | Paris | 75013 | France |
| Pfizer Investigational Site | Paris | 75018 | France |
| Pfizer Investigational Site | Pau | 64000 | France |
| Pfizer Investigational Site | Perpignan | 66000 | France |
| Pfizer Investigational Site | Poissy | 78300 | France |
| Pfizer Investigational Site | Quetigny | 21800 | France |
| Pfizer Investigational Site | Rillieux-la-Pape | 69140 | France |
| Pfizer Investigational Site | Roanne | 42300 | France |
| Pfizer Investigational Site | Roquebrune-Cap-Martin | 06190 | France |
| Pfizer Investigational Site | Roye | 80700 | France |
| Pfizer Investigational Site | Saint-Girons | 09200 | France |
| Pfizer Investigational Site | Saint-Laurent-du-Var | 06700 | France |
| Pfizer Investigational Site | Saint-Maur-des-Fossés | 94100 | France |
| Pfizer Investigational Site | Saint-Quentin | 02100 | France |
| Pfizer Investigational Site | Sainte-Maure-de-Touraine | 37800 | France |
| Pfizer Investigational Site | Saintes | 17100 | France |
| Pfizer Investigational Site | Salon-de-Provence | 13300 | France |
| Pfizer Investigational Site | Sceaux | 92330 | France |
| Pfizer Investigational Site | Toulon | 83000 | France |
| Pfizer Investigational Site | Toulouse | 31000 | France |
| Pfizer Investigational Site | Tremblay-en-France | 93290 | France |
| Pfizer Investigational Site | Troyes | 10000 | France |
| Pfizer Investigational Site | Vauvert | 30600 | France |
| Pfizer Investigational Site | Vendôme | 41100 | France |
| Pfizer Investigational Site | Versailles | 78000 | France |
| Pfizer Investigational Site | Viarmes | 95270 | France |
| Pfizer Investigational Site | Villeneuve-la-Garenne | 92390 | France |
| Pfizer Investigational Site | Villeparisis | 77270 | France |
| Pfizer Investigational Site | Villiers-le-Bel | 95400 | France |
| Pfizer Investigational Site | Wasselonne | 67310 | France |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D013999 | Timolol |
| C571753 | Xalacom |
| D014792 | Visual Acuity |
| ID | Term |
|---|---|
| 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 |
| 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 |
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009799 | Ocular Physiological Phenomena |
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