A Study to Assess the Efficacy of 3 Months of Latanoprost Treatment in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-angle Glaucoma
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00647101
Collaborator
(none)
600
176
1
14.1
3.4
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
600 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg
Study Start Date
:
Dec 1, 2003
Actual Study Completion Date
:
Feb 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Latanoprost group
|
Drug: Latanoprost
Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months
|
Outcome Measures
Primary Outcome Measures
- Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP [3 months]
Secondary Outcome Measures
- Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP [3 months]
- Proportion of patients after 3 months of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10% [3 months]
- Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP [1 month]
- Proportion of patients after 1 month of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10% [1 month]
- Proportion of patients after 3 months of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg [3 months]
- Proportion of patients after 1 month of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg [1 month]
- Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam [3 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
A patient with an IOP greater than or equal to 20 mmHg related to unilateral or bilateral OH or OAG (primary open angle glaucoma, pseudo-exfoliative glaucoma, and pigmentary glaucoma), after a visual field exam
-
Naive patients (i.e. never having been treated) and requiring treatment initiation
Exclusion Criteria:
-
A patient with OH or OAG currently on treatment
-
A patient with OH or OAG previously treated (regardless of the date treatment was discontinued)
-
A patient with traumatic, inflammatory, or neovascular glaucoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Albi | France | 81000 | |
| 2 | Pfizer Investigational Site | Ambert | France | 63600 | |
| 3 | Pfizer Investigational Site | Amboise | France | 37400 | |
| 4 | Pfizer Investigational Site | Angers | France | 49100 | |
| 5 | Pfizer Investigational Site | Antibes | France | 06600 | |
| 6 | Pfizer Investigational Site | Aubenas | France | 07200 | |
| 7 | Pfizer Investigational Site | Belfort | France | 90000 | |
| 8 | Pfizer Investigational Site | Bergerac | France | 24100 | |
| 9 | Pfizer Investigational Site | Bernay | France | 27300 | |
| 10 | Pfizer Investigational Site | Bethune | France | 62400 | |
| 11 | Pfizer Investigational Site | Beziers | France | 34500 | |
| 12 | Pfizer Investigational Site | Blagnac | France | 31700 | |
| 13 | Pfizer Investigational Site | Bordeaux | France | 33000 | |
| 14 | Pfizer Investigational Site | Bordeaux | France | 33100 | |
| 15 | Pfizer Investigational Site | Bougival | France | 78380 | |
| 16 | Pfizer Investigational Site | Boulogne-Billancourt | France | 92100 | |
| 17 | Pfizer Investigational Site | Brest | France | 29200 | |
| 18 | Pfizer Investigational Site | Bry Sur Marne | France | 94360 | |
| 19 | Pfizer Investigational Site | Carentan | France | 50500 | |
| 20 | Pfizer Investigational Site | Cenon | France | 33150 | |
| 21 | Pfizer Investigational Site | Chamalieres | France | 63400 | |
| 22 | Pfizer Investigational Site | Chantilly | France | 60500 | |
| 23 | Pfizer Investigational Site | Chartres | France | 28000 | |
| 24 | Pfizer Investigational Site | Chateaubriant | France | 44110 | |
| 25 | Pfizer Investigational Site | Chateaulin | France | 29150 | |
| 26 | Pfizer Investigational Site | Clermont-Ferrand | France | 63100 | |
| 27 | Pfizer Investigational Site | Condom | France | 32100 | |
| 28 | Pfizer Investigational Site | Coulommiers | France | 77120 | |
| 29 | Pfizer Investigational Site | Courbevoie | France | 92400 | |
| 30 | Pfizer Investigational Site | Creil | France | 60100 | |
| 31 | Pfizer Investigational Site | Deauville | France | 14800 | |
| 32 | Pfizer Investigational Site | Deuil la Barre | France | 95170 | |
| 33 | Pfizer Investigational Site | Douai | France | 59500 | |
| 34 | Pfizer Investigational Site | Draveil | France | 91210 | |
| 35 | Pfizer Investigational Site | Enghien Les Bains | France | 95880 | |
| 36 | Pfizer Investigational Site | Epernay | France | 51200 | |
| 37 | Pfizer Investigational Site | Fontaine | France | 38600 | |
| 38 | Pfizer Investigational Site | Frejus | France | 83600 | |
| 39 | Pfizer Investigational Site | Gennevilliers | France | 92230 | |
| 40 | Pfizer Investigational Site | Gradignan | France | 33170 | |
| 41 | Pfizer Investigational Site | Grasse | France | 06130 | |
| 42 | Pfizer Investigational Site | Grasse | France | 06135 | |
| 43 | Pfizer Investigational Site | Grenoble | France | 38000 | |
| 44 | Pfizer Investigational Site | Grenoble | France | 38100 | |
| 45 | Pfizer Investigational Site | Guingamp | France | 22200 | |
| 46 | Pfizer Investigational Site | Haguenau | France | 67500 | |
| 47 | Pfizer Investigational Site | Herblay | France | 95220 | |
| 48 | Pfizer Investigational Site | Hyeres | France | 83400 | |
| 49 | Pfizer Investigational Site | Issy Les Moulineaux | France | 92130 | |
| 50 | Pfizer Investigational Site | Ivry Sur Seine | France | 94210 | |
| 51 | Pfizer Investigational Site | Jarville La Malgrange | France | 5414 | |
| 52 | Pfizer Investigational Site | Joigny | France | 89300 | |
| 53 | Pfizer Investigational Site | Juvisy Sur Orge | France | 91260 | |
| 54 | Pfizer Investigational Site | La Rochelle | France | 17000 | |
| 55 | Pfizer Investigational Site | La Talaudiere | France | 42350 | |
| 56 | Pfizer Investigational Site | La Trinite | France | 06340 | |
| 57 | Pfizer Investigational Site | Landerneau | France | 29800 | |
| 58 | Pfizer Investigational Site | Langon | France | 33210 | |
| 59 | Pfizer Investigational Site | Lannion | France | 22300 | |
| 60 | Pfizer Investigational Site | Laon | France | 02000 | |
| 61 | Pfizer Investigational Site | Le Creuzot | France | 71200 | |
| 62 | Pfizer Investigational Site | Le Havre | France | 76600 | |
| 63 | Pfizer Investigational Site | Le Mans | France | 72000 | |
| 64 | Pfizer Investigational Site | Le Peage De Rousillon | France | 38550 | |
| 65 | Pfizer Investigational Site | Le Quesnoy | France | 59530 | |
| 66 | Pfizer Investigational Site | Lesneven | France | 29260 | |
| 67 | Pfizer Investigational Site | Lille | France | 59000 | |
| 68 | Pfizer Investigational Site | Livry Gargan | France | 93190 | |
| 69 | Pfizer Investigational Site | Lunel | France | 34400 | |
| 70 | Pfizer Investigational Site | Luneville | France | 54300 | |
| 71 | Pfizer Investigational Site | Luxeuil les Bains | France | 70300 | |
| 72 | Pfizer Investigational Site | Lyon | France | 69002 | |
| 73 | Pfizer Investigational Site | Lyon | France | 69006 | |
| 74 | Pfizer Investigational Site | Lyon | France | 69008 | |
| 75 | Pfizer Investigational Site | Lyon | France | 69437 | |
| 76 | Pfizer Investigational Site | Maisons Laffitte | France | 78600 | |
| 77 | Pfizer Investigational Site | Marcq en Baroeul | France | 59700 | |
| 78 | Pfizer Investigational Site | Marignanne | France | 13700 | |
| 79 | Pfizer Investigational Site | Marseille | France | 13001 | |
| 80 | Pfizer Investigational Site | Marseille | France | 13004 | |
| 81 | Pfizer Investigational Site | Marseille | France | 13008 | |
| 82 | Pfizer Investigational Site | MArseille | France | 13009 | |
| 83 | Pfizer Investigational Site | Marseille | France | 13012 | |
| 84 | Pfizer Investigational Site | Meyzieu | France | 69330 | |
| 85 | Pfizer Investigational Site | Montauban | France | 82000 | |
| 86 | Pfizer Investigational Site | Montceau Les Mines | France | 71300 | |
| 87 | Pfizer Investigational Site | Montpellier | France | 34000 | |
| 88 | Pfizer Investigational Site | Mulhouse | France | 68200 | |
| 89 | Pfizer Investigational Site | Nantes | France | 44000 | |
| 90 | Pfizer Investigational Site | Nice | France | 06000 | |
| 91 | Pfizer Investigational Site | Nice | France | 06300 | |
| 92 | Pfizer Investigational Site | Nimes Cedex 2 | France | 30918 | |
| 93 | Pfizer Investigational Site | Nimes | France | 30000 | |
| 94 | Pfizer Investigational Site | Niort | France | 79000 | |
| 95 | Pfizer Investigational Site | Nogent Sur Marne | France | 94130 | |
| 96 | Pfizer Investigational Site | Noyon | France | 60400 | |
| 97 | Pfizer Investigational Site | Orleans | France | 45000 | |
| 98 | Pfizer Investigational Site | Oullins | France | 69600 | |
| 99 | Pfizer Investigational Site | Pantin | France | 93500 | |
| 100 | Pfizer Investigational Site | Paray le Monial | France | 71600 | |
| 101 | Pfizer Investigational Site | Paris | France | 75006 | |
| 102 | Pfizer Investigational Site | Paris | France | 75008 | |
| 103 | Pfizer Investigational Site | Paris | France | 75009 | |
| 104 | Pfizer Investigational Site | Paris | France | 75010 | |
| 105 | Pfizer Investigational Site | Paris | France | 75012 | |
| 106 | Pfizer Investigational Site | Paris | France | 75013 | |
| 107 | Pfizer Investigational Site | Paris | France | 75014 | |
| 108 | Pfizer Investigational Site | Paris | France | 75015 | |
| 109 | Pfizer Investigational Site | Paris | France | 75016 | |
| 110 | Pfizer Investigational Site | Paris | France | 75018 | |
| 111 | Pfizer Investigational Site | Paris | France | 75019 | |
| 112 | Pfizer Investigational Site | Paris | France | 75020 | |
| 113 | Pfizer Investigational Site | Paris | France | 75116 | |
| 114 | Pfizer Investigational Site | Pauillac | France | 33250 | |
| 115 | Pfizer Investigational Site | Pau | France | 64000 | |
| 116 | Pfizer Investigational Site | Perigueux | France | 24000 | |
| 117 | Pfizer Investigational Site | Perros Girec | France | 22700 | |
| 118 | Pfizer Investigational Site | Pezenas | France | 34120 | |
| 119 | Pfizer Investigational Site | Poissy | France | 78300 | |
| 120 | Pfizer Investigational Site | Poitiers | France | 86000 | |
| 121 | Pfizer Investigational Site | Pont de Cheruy | France | 38230 | |
| 122 | Pfizer Investigational Site | Pornic | France | 44210 | |
| 123 | Pfizer Investigational Site | Port De Bouc | France | 13110 | |
| 124 | Pfizer Investigational Site | Quimper | France | 29000 | |
| 125 | Pfizer Investigational Site | Reims | France | 51100 | |
| 126 | Pfizer Investigational Site | Rochefort | France | 17300 | |
| 127 | Pfizer Investigational Site | Romilly sur Seine | France | 10100 | |
| 128 | Pfizer Investigational Site | Saint Die des Vosges | France | 88100 | |
| 129 | Pfizer Investigational Site | Saint Etienne | France | 42000 | |
| 130 | Pfizer Investigational Site | Saint Gaudens | France | 31800 | |
| 131 | Pfizer Investigational Site | Saint Savine | France | 10300 | |
| 132 | Pfizer Investigational Site | Saintes | France | 17100 | |
| 133 | Pfizer Investigational Site | Salon de Provence | France | 13300 | |
| 134 | Pfizer Investigational Site | Sartrouville | France | 78500 | |
| 135 | Pfizer Investigational Site | Sens | France | 89100 | |
| 136 | Pfizer Investigational Site | Sessiney Pariset | France | 38170 | |
| 137 | Pfizer Investigational Site | Sete | France | 34200 | |
| 138 | Pfizer Investigational Site | Soissons | France | 02209 | |
| 139 | Pfizer Investigational Site | St Chamond | France | 42200 | |
| 140 | Pfizer Investigational Site | St Etienne | France | 42100 | |
| 141 | Pfizer Investigational Site | St Michel Sur Orge | France | 91240 | |
| 142 | Pfizer Investigational Site | St. Brieuc | France | 22015 | |
| 143 | Pfizer Investigational Site | St. Lo | France | 50000 | |
| 144 | Pfizer Investigational Site | Strasbourg | France | 67000 | |
| 145 | Pfizer Investigational Site | Strasbourg | France | 67200 | |
| 146 | Pfizer Investigational Site | Suresnes | France | 92150 | |
| 147 | Pfizer Investigational Site | Talence | France | 33400 | |
| 148 | Pfizer Investigational Site | Thiers | France | 63300 | |
| 149 | Pfizer Investigational Site | Toulon | France | 83000 | |
| 150 | Pfizer Investigational Site | Toulouse | France | 31500 | |
| 151 | Pfizer Investigational Site | Toulouse | France | 34100 | |
| 152 | Pfizer Investigational Site | Tourcoing | France | 59200 | |
| 153 | Pfizer Investigational Site | Tournefeuille | France | 31170 | |
| 154 | Pfizer Investigational Site | Tours | France | 37000 | |
| 155 | Pfizer Investigational Site | Trelissac | France | 24750 | |
| 156 | Pfizer Investigational Site | Tremblay en France | France | 93290 | |
| 157 | Pfizer Investigational Site | Triel Sur Seine | France | 78510 | |
| 158 | Pfizer Investigational Site | Troyes | France | 10000 | |
| 159 | Pfizer Investigational Site | Valenciennes | France | 59300 | |
| 160 | Pfizer Investigational Site | Vannes | France | 56000 | |
| 161 | Pfizer Investigational Site | Vauvert | France | 30600 | |
| 162 | Pfizer Investigational Site | Veauche | France | 42340 | |
| 163 | Pfizer Investigational Site | Velaux | France | 13800 | |
| 164 | Pfizer Investigational Site | Vendargues | France | 34740 | |
| 165 | Pfizer Investigational Site | Venissieux Cedex | France | 69694 | |
| 166 | Pfizer Investigational Site | Viarmes | France | 95270 | |
| 167 | Pfizer Investigational Site | Vienne | France | 38200 | |
| 168 | Pfizer Investigational Site | Villeneuve D'Ascq | France | 59650 | |
| 169 | Pfizer Investigational Site | Villeneuve la Garenne | France | 92390 | |
| 170 | Pfizer Investigational Site | Villeneuve Saint Georges | France | 94190 | |
| 171 | Pfizer Investigational Site | Villeparisis | France | 77270 | |
| 172 | Pfizer Investigational Site | Villepinte | France | 93420 | |
| 173 | Pfizer Investigational Site | Villiers Le Bel | France | 95400 | |
| 174 | Pfizer Investigational Site | Vizille | France | 38220 | |
| 175 | Pfizer Investigational Site | Voiron | France | 38500 | |
| 176 | Pfizer Investigational Site | Wattrelos | France | 59150 |
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
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00647101
Other Study ID Numbers:
- A6111002
- X-FIL
First Posted:
Mar 31, 2008
Last Update Posted:
Feb 2, 2021
Last Verified:
Mar 1, 2008
Additional relevant MeSH terms: