Clinical trial NCT00647101: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP
timeFrame: 3 months
Secondary outcomes:
measure: Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP
timeFrame: 3 months
measure: 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%
timeFrame: 3 months
measure: Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP
timeFrame: 1 month
measure: 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%
timeFrame: 1 month
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 1 month
measure: Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam
timeFrame: 3 months
Other outcomes:
Locations:
city: Albi
country: France
facility: Pfizer Investigational Site
city: Ambert
country: France
facility: Pfizer Investigational Site
city: Amboise
country: France
facility: Pfizer Investigational Site
city: Angers
country: France
facility: Pfizer Investigational Site
city: Antibes
country: France
facility: Pfizer Investigational Site
city: Aubenas
country: France
facility: Pfizer Investigational Site
city: Belfort
country: France
facility: Pfizer Investigational Site
city: Bergerac
country: France
facility: Pfizer Investigational Site
city: Bernay
country: France
facility: Pfizer Investigational Site
city: Bethune
country: France
facility: Pfizer Investigational Site
city: Beziers
country: France
facility: Pfizer Investigational Site
city: Blagnac
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Bougival
country: France
facility: Pfizer Investigational Site
city: Boulogne-Billancourt
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Bry Sur Marne
country: France
facility: Pfizer Investigational Site
city: Carentan
country: France
facility: Pfizer Investigational Site
city: Cenon
country: France
facility: Pfizer Investigational Site
city: Chamalieres
country: France
facility: Pfizer Investigational Site
city: Chantilly
country: France
facility: Pfizer Investigational Site
city: Chartres
country: France
facility: Pfizer Investigational Site
city: Chateaubriant
country: France
facility: Pfizer Investigational Site
city: Chateaulin
country: France
facility: Pfizer Investigational Site
city: Clermont-Ferrand
country: France
facility: Pfizer Investigational Site
city: Condom
country: France
facility: Pfizer Investigational Site
city: Coulommiers
country: France
facility: Pfizer Investigational Site
city: Courbevoie
country: France
facility: Pfizer Investigational Site
city: Creil
country: France
facility: Pfizer Investigational Site
city: Deauville
country: France
facility: Pfizer Investigational Site
city: Deuil la Barre
country: France
facility: Pfizer Investigational Site
city: Douai
country: France
facility: Pfizer Investigational Site
city: Draveil
country: France
facility: Pfizer Investigational Site
city: Enghien Les Bains
country: France
facility: Pfizer Investigational Site
city: Epernay
country: France
facility: Pfizer Investigational Site
city: Fontaine
country: France
facility: Pfizer Investigational Site
city: Frejus
country: France
facility: Pfizer Investigational Site
city: Gennevilliers
country: France
facility: Pfizer Investigational Site
city: Gradignan
country: France
facility: Pfizer Investigational Site
city: Grasse
country: France
facility: Pfizer Investigational Site
city: Grasse
country: France
facility: Pfizer Investigational Site
city: Grenoble
country: France
facility: Pfizer Investigational Site
city: Grenoble
country: France
facility: Pfizer Investigational Site
city: Guingamp
country: France
facility: Pfizer Investigational Site
city: Haguenau
country: France
facility: Pfizer Investigational Site
city: Herblay
country: France
facility: Pfizer Investigational Site
city: Hyeres
country: France
facility: Pfizer Investigational Site
city: Issy Les Moulineaux
country: France
facility: Pfizer Investigational Site
city: Ivry Sur Seine
country: France
facility: Pfizer Investigational Site
city: Jarville La Malgrange
country: France
facility: Pfizer Investigational Site
city: Joigny
country: France
facility: Pfizer Investigational Site
city: Juvisy Sur Orge
country: France
facility: Pfizer Investigational Site
city: La Rochelle
country: France
facility: Pfizer Investigational Site
city: La Talaudiere
country: France
facility: Pfizer Investigational Site
city: La Trinite
country: France
facility: Pfizer Investigational Site
city: Landerneau
country: France
facility: Pfizer Investigational Site
city: Langon
country: France
facility: Pfizer Investigational Site
city: Lannion
country: France
facility: Pfizer Investigational Site
city: Laon
country: France
facility: Pfizer Investigational Site
city: Le Creuzot
country: France
facility: Pfizer Investigational Site
city: Le Havre
country: France
facility: Pfizer Investigational Site
city: Le Mans
country: France
facility: Pfizer Investigational Site
city: Le Peage De Rousillon
country: France
facility: Pfizer Investigational Site
city: Le Quesnoy
country: France
facility: Pfizer Investigational Site
city: Lesneven
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Livry Gargan
country: France
facility: Pfizer Investigational Site
city: Lunel
country: France
facility: Pfizer Investigational Site
city: Luneville
country: France
facility: Pfizer Investigational Site
city: Luxeuil les Bains
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Maisons Laffitte
country: France
facility: Pfizer Investigational Site
city: Marcq en Baroeul
country: France
facility: Pfizer Investigational Site
city: Marignanne
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: MArseille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Meyzieu
country: France
facility: Pfizer Investigational Site
city: Montauban
country: France
facility: Pfizer Investigational Site
city: Montceau Les Mines
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Mulhouse
country: France
facility: Pfizer Investigational Site
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Nimes Cedex 2
country: France
facility: Pfizer Investigational Site
city: Nimes
country: France
facility: Pfizer Investigational Site
city: Niort
country: France
facility: Pfizer Investigational Site
city: Nogent Sur Marne
country: France
facility: Pfizer Investigational Site
city: Noyon
country: France
facility: Pfizer Investigational Site
city: Orleans
country: France
facility: Pfizer Investigational Site
city: Oullins
country: France
facility: Pfizer Investigational Site
city: Pantin
country: France
facility: Pfizer Investigational Site
city: Paray le Monial
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Pauillac
country: France
facility: Pfizer Investigational Site
city: Pau
country: France
facility: Pfizer Investigational Site
city: Perigueux
country: France
facility: Pfizer Investigational Site
city: Perros Girec
country: France
facility: Pfizer Investigational Site
city: Pezenas
country: France
facility: Pfizer Investigational Site
city: Poissy
country: France
facility: Pfizer Investigational Site
city: Poitiers
country: France
facility: Pfizer Investigational Site
city: Pont de Cheruy
country: France
facility: Pfizer Investigational Site
city: Pornic
country: France
facility: Pfizer Investigational Site
city: Port De Bouc
country: France
facility: Pfizer Investigational Site
city: Quimper
country: France
facility: Pfizer Investigational Site
city: Reims
country: France
facility: Pfizer Investigational Site
city: Rochefort
country: France
facility: Pfizer Investigational Site
city: Romilly sur Seine
country: France
facility: Pfizer Investigational Site
city: Saint Die des Vosges
country: France
facility: Pfizer Investigational Site
city: Saint Etienne
country: France
facility: Pfizer Investigational Site
city: Saint Gaudens
country: France
facility: Pfizer Investigational Site
city: Saint Savine
country: France
facility: Pfizer Investigational Site
city: Saintes
country: France
facility: Pfizer Investigational Site
city: Salon de Provence
country: France
facility: Pfizer Investigational Site
city: Sartrouville
country: France
facility: Pfizer Investigational Site
city: Sens
country: France
facility: Pfizer Investigational Site
city: Sessiney Pariset
country: France
facility: Pfizer Investigational Site
city: Sete
country: France
facility: Pfizer Investigational Site
city: Soissons
country: France
facility: Pfizer Investigational Site
city: St Chamond
country: France
facility: Pfizer Investigational Site
city: St Etienne
country: France
facility: Pfizer Investigational Site
city: St Michel Sur Orge
country: France
facility: Pfizer Investigational Site
city: St. Brieuc
country: France
facility: Pfizer Investigational Site
city: St. Lo
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Suresnes
country: France
facility: Pfizer Investigational Site
city: Talence
country: France
facility: Pfizer Investigational Site
city: Thiers
country: France
facility: Pfizer Investigational Site
city: Toulon
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Tourcoing
country: France
facility: Pfizer Investigational Site
city: Tournefeuille
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Trelissac
country: France
facility: Pfizer Investigational Site
city: Tremblay en France
country: France
facility: Pfizer Investigational Site
city: Triel Sur Seine
country: France
facility: Pfizer Investigational Site
city: Troyes
country: France
facility: Pfizer Investigational Site
city: Valenciennes
country: France
facility: Pfizer Investigational Site
city: Vannes
country: France
facility: Pfizer Investigational Site
city: Vauvert
country: France
facility: Pfizer Investigational Site
city: Veauche
country: France
facility: Pfizer Investigational Site
city: Velaux
country: France
facility: Pfizer Investigational Site
city: Vendargues
country: France
facility: Pfizer Investigational Site
city: Venissieux Cedex
country: France
facility: Pfizer Investigational Site
city: Viarmes
country: France
facility: Pfizer Investigational Site
city: Vienne
country: France
facility: Pfizer Investigational Site
city: Villeneuve D'Ascq
country: France
facility: Pfizer Investigational Site
city: Villeneuve la Garenne
country: France
facility: Pfizer Investigational Site
city: Villeneuve Saint Georges
country: France
facility: Pfizer Investigational Site
city: Villeparisis
country: France
facility: Pfizer Investigational Site
city: Villepinte
country: France
facility: Pfizer Investigational Site
city: Villiers Le Bel
country: France
facility: Pfizer Investigational Site
city: Vizille
country: France
facility: Pfizer Investigational Site
city: Voiron
country: France
facility: Pfizer Investigational Site
city: Wattrelos
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.