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
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
2 other identifiers
interventional
600
1 country
176
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2003
176 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedFebruary 2, 2021
March 1, 2008
March 26, 2008
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP
3 months
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Latanoprost group
EXPERIMENTALInterventions
Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (176)
Pfizer Investigational Site
Albi, 81000, France
Pfizer Investigational Site
Ambert, 63600, France
Pfizer Investigational Site
Amboise, 37400, France
Pfizer Investigational Site
Angers, 49100, France
Pfizer Investigational Site
Antibes, 06600, France
Pfizer Investigational Site
Aubenas, 07200, France
Pfizer Investigational Site
Belfort, 90000, France
Pfizer Investigational Site
Bergerac, 24100, France
Pfizer Investigational Site
Bernay, 27300, France
Pfizer Investigational Site
Béthune, 62400, France
Pfizer Investigational Site
Béziers, 34500, France
Pfizer Investigational Site
Blagnac, 31700, France
Pfizer Investigational Site
Bordeaux, 33000, France
Pfizer Investigational Site
Bordeaux, 33100, France
Pfizer Investigational Site
Bougival, 78380, France
Pfizer Investigational Site
Boulogne-Billancourt, 92100, France
Pfizer Investigational Site
Brest, 29200, France
Pfizer Investigational Site
Bry-sur-Marne, 94360, France
Pfizer Investigational Site
Carentan, 50500, France
Pfizer Investigational Site
Cenon, 33150, France
Pfizer Investigational Site
Chamalières, 63400, France
Pfizer Investigational Site
Chantilly, 60500, France
Pfizer Investigational Site
Chartres, 28000, France
Pfizer Investigational Site
Châteaubriant, 44110, France
Pfizer Investigational Site
Châteaulin, 29150, France
Pfizer Investigational Site
Clermont-Ferrand, 63100, France
Pfizer Investigational Site
Condom, 32100, France
Pfizer Investigational Site
Coulommiers, 77120, France
Pfizer Investigational Site
Courbevoie, 92400, France
Pfizer Investigational Site
Creil, 60100, France
Pfizer Investigational Site
Deauville, 14800, France
Pfizer Investigational Site
Deuil-la-Barre, 95170, France
Pfizer Investigational Site
Douai, 59500, France
Pfizer Investigational Site
Draveil, 91210, France
Pfizer Investigational Site
Enghien-les-Bains, 95880, France
Pfizer Investigational Site
Épernay, 51200, France
Pfizer Investigational Site
Fontaine, 38600, France
Pfizer Investigational Site
Fréjus, 83600, France
Pfizer Investigational Site
Gennevilliers, 92230, France
Pfizer Investigational Site
Gradignan, 33170, France
Pfizer Investigational Site
Grasse, 06130, France
Pfizer Investigational Site
Grasse, 06135, France
Pfizer Investigational Site
Grenoble, 38000, France
Pfizer Investigational Site
Grenoble, 38100, France
Pfizer Investigational Site
Guingamp, 22200, France
Pfizer Investigational Site
Haguenau, 67500, France
Pfizer Investigational Site
Herblay-sur-Seine, 95220, France
Pfizer Investigational Site
Hyères, 83400, France
Pfizer Investigational Site
Issy-les-Moulineaux, 92130, France
Pfizer Investigational Site
Ivry-sur-Seine, 94210, France
Pfizer Investigational Site
Jarville-la-Malgrange, 5414, France
Pfizer Investigational Site
Joigny, 89300, France
Pfizer Investigational Site
Juvisy-sur-Orge, 91260, France
Pfizer Investigational Site
La Rochelle, 17000, France
Pfizer Investigational Site
La Talaudière, 42350, France
Pfizer Investigational Site
La Trinité, 06340, France
Pfizer Investigational Site
Landerneau, 29800, France
Pfizer Investigational Site
Langon, 33210, France
Pfizer Investigational Site
Lannion, 22300, France
Pfizer Investigational Site
Laon, 02000, France
Pfizer Investigational Site
Le Creuzot, 71200, France
Pfizer Investigational Site
Le Havre, 76600, France
Pfizer Investigational Site
Le Mans, 72000, France
Pfizer Investigational Site
Le Peage de Rousillon, 38550, France
Pfizer Investigational Site
Le Quesnoy, 59530, France
Pfizer Investigational Site
Lesneven, 29260, France
Pfizer Investigational Site
Lille, 59000, France
Pfizer Investigational Site
Livry-Gargan, 93190, France
Pfizer Investigational Site
Lunel, 34400, France
Pfizer Investigational Site
Lunéville, 54300, France
Pfizer Investigational Site
Luxeuil-les-Bains, 70300, France
Pfizer Investigational Site
Lyon, 69002, France
Pfizer Investigational Site
Lyon, 69006, France
Pfizer Investigational Site
Lyon, 69008, France
Pfizer Investigational Site
Lyon, 69437, France
Pfizer Investigational Site
Maisons-Laffitte, 78600, France
Pfizer Investigational Site
Marcq-en-Barœul, 59700, France
Pfizer Investigational Site
Marignanne, 13700, France
Pfizer Investigational Site
Marseille, 13001, France
Pfizer Investigational Site
Marseille, 13004, France
Pfizer Investigational Site
Marseille, 13008, France
Pfizer Investigational Site
Marseille, 13009, France
Pfizer Investigational Site
Marseille, 13012, France
Pfizer Investigational Site
Meyzieu, 69330, France
Pfizer Investigational Site
Montauban, 82000, France
Pfizer Investigational Site
Montceau-les-Mines, 71300, France
Pfizer Investigational Site
Montpellier, 34000, France
Pfizer Investigational Site
Mulhouse, 68200, France
Pfizer Investigational Site
Nantes, 44000, France
Pfizer Investigational Site
Nice, 06000, France
Pfizer Investigational Site
Nice, 06300, France
Pfizer Investigational Site
Niort, 79000, France
Pfizer Investigational Site
Nîmes, 30000, France
Pfizer Investigational Site
Nîmes, 30918, France
Pfizer Investigational Site
Nogent-sur-Marne, 94130, France
Pfizer Investigational Site
Noyon, 60400, France
Pfizer Investigational Site
Orléans, 45000, France
Pfizer Investigational Site
Oullins, 69600, France
Pfizer Investigational Site
Pantin, 93500, France
Pfizer Investigational Site
Paray-le-Monial, 71600, France
Pfizer Investigational Site
Paris, 75006, France
Pfizer Investigational Site
Paris, 75008, France
Pfizer Investigational Site
Paris, 75009, France
Pfizer Investigational Site
Paris, 75010, France
Pfizer Investigational Site
Paris, 75012, France
Pfizer Investigational Site
Paris, 75013, France
Pfizer Investigational Site
Paris, 75014, France
Pfizer Investigational Site
Paris, 75015, France
Pfizer Investigational Site
Paris, 75016, France
Pfizer Investigational Site
Paris, 75018, France
Pfizer Investigational Site
Paris, 75019, France
Pfizer Investigational Site
Paris, 75020, France
Pfizer Investigational Site
Paris, 75116, France
Pfizer Investigational Site
Pau, 64000, France
Pfizer Investigational Site
Pauillac, 33250, France
Pfizer Investigational Site
Perros Girec, 22700, France
Pfizer Investigational Site
Périgueux, 24000, France
Pfizer Investigational Site
Pézenas, 34120, France
Pfizer Investigational Site
Poissy, 78300, France
Pfizer Investigational Site
Poitiers, 86000, France
Pfizer Investigational Site
Pont-de-Chéruy, 38230, France
Pfizer Investigational Site
Pornic, 44210, France
Pfizer Investigational Site
Port-de-Bouc, 13110, France
Pfizer Investigational Site
Quimper, 29000, France
Pfizer Investigational Site
Reims, 51100, France
Pfizer Investigational Site
Rochefort, 17300, France
Pfizer Investigational Site
Romilly-sur-Seine, 10100, France
Pfizer Investigational Site
Saint Savine, 10300, France
Pfizer Investigational Site
Saint-Brieuc, 22015, France
Pfizer Investigational Site
Saint-Chamond, 42200, France
Pfizer Investigational Site
Saint-Dié, 88100, France
Pfizer Investigational Site
Saint-Etienne, 42000, France
Pfizer Investigational Site
Saint-Etienne, 42100, France
Pfizer Investigational Site
Saint-Gaudens, 31800, France
Pfizer Investigational Site
Saint-Lô, 50000, France
Pfizer Investigational Site
Saint-Michel-sur-Orge, 91240, France
Pfizer Investigational Site
Saintes, 17100, France
Pfizer Investigational Site
Salon-de-Provence, 13300, France
Pfizer Investigational Site
Sartrouville, 78500, France
Pfizer Investigational Site
Sens, 89100, France
Pfizer Investigational Site
Sessiney Pariset, 38170, France
Pfizer Investigational Site
Sète, 34200, France
Pfizer Investigational Site
Soissons, 02209, France
Pfizer Investigational Site
Strasbourg, 67000, France
Pfizer Investigational Site
Strasbourg, 67200, France
Pfizer Investigational Site
Suresnes, 92150, France
Pfizer Investigational Site
Talence, 33400, France
Pfizer Investigational Site
Thiers, 63300, France
Pfizer Investigational Site
Toulon, 83000, France
Pfizer Investigational Site
Toulouse, 31500, France
Pfizer Investigational Site
Toulouse, 34100, France
Pfizer Investigational Site
Tourcoing, 59200, France
Pfizer Investigational Site
Tournefeuille, 31170, France
Pfizer Investigational Site
Tours, 37000, France
Pfizer Investigational Site
Tremblay-en-France, 93290, France
Pfizer Investigational Site
Trélissac, 24750, France
Pfizer Investigational Site
Triel-sur-Seine, 78510, France
Pfizer Investigational Site
Troyes, 10000, France
Pfizer Investigational Site
Valenciennes, 59300, France
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Vannes, 56000, France
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Vauvert, 30600, France
Pfizer Investigational Site
Veauche, 42340, France
Pfizer Investigational Site
Velaux, 13800, France
Pfizer Investigational Site
Vendargues, 34740, France
Pfizer Investigational Site
Vénissieux, 69694, France
Pfizer Investigational Site
Viarmes, 95270, France
Pfizer Investigational Site
Vienne, 38200, France
Pfizer Investigational Site
Villeneuve-d'Ascq, 59650, France
Pfizer Investigational Site
Villeneuve-la-Garenne, 92390, France
Pfizer Investigational Site
Villeneuve-Saint-Georges, 94190, France
Pfizer Investigational Site
Villeparisis, 77270, France
Pfizer Investigational Site
Villepinte, 93420, France
Pfizer Investigational Site
Villiers-le-Bel, 95400, France
Pfizer Investigational Site
Vizille, 38220, France
Pfizer Investigational Site
Voiron, 38500, France
Pfizer Investigational Site
Wattrelos, 59150, France
Related Publications (1)
Denis P, Baudouin C, Bron A, Nordmann JP, Renard JP, Rouland JF, Sellem E, Amrane M. First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial intraocular pressure. BMC Ophthalmol. 2010 Feb 24;10:4. doi: 10.1186/1471-2415-10-4.
PMID: 20181282DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 31, 2008
Study Start
December 1, 2003
Study Completion
February 1, 2005
Last Updated
February 2, 2021
Record last verified: 2008-03