Clinical trial NCT00230763: Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure
Official title: Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure After A 12-Week Treatment With Latanoprost 0.005% / Timolol 0.5% Fixed Combination (Xalacom) In Previously Treated Patients With Open Angle Glaucoma Or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Primary Open Angle (POAG)
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-03
Enrollment: 396
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: 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).


Eligibility criteria: Inclusion Criteria:

* Male or female patients,
* Aged \> than equal to 18 years,
* Patient presenting with an OHT or OAG with an IOP � 21 mmHg,
* Patient currently treated with ophthalmic beta-blockers monotherapy and requiring a change of the ophthalmic medication due to insufficient response to treatment,

Exclusion Criteria:

* Patient currently treated by or having received within the last month any ophthalmic hypotensive agent other than a beta-blocker,
* Patient presenting any contraindication to latanoprost or timolol,
* Patient with history of asthma, obstructive broncho-pneumopathy, sinusal bradycardia (pulse rate \< 60 bpm), auriculo-ventricular block, cardiac insufficiency, Raynaud disease or any other condition that would preclude the patient from taking the prescribed medication,
* Patient with known intolerance to benzalkonium chloride or any excipient contained in the trial treatment,

Primary outcomes:
measure: A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Absolute and relative IOP change after 4 and 12 weeks of treatment
timeFrame: week 4 and 12
measure: Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,
timeFrame: week 12
Other outcomes:
Locations:
city: Agen
country: France
facility: Pfizer Investigational Site
city: Amboise
country: France
facility: Pfizer Investigational Site
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Andresy
country: France
facility: Pfizer Investigational Site
city: Asnieres Sur Seine
country: France
facility: Pfizer Investigational Site
city: Aubiere
country: France
facility: Pfizer Investigational Site
city: Aurillac
country: France
facility: Pfizer Investigational Site
city: Belfort
country: France
facility: Pfizer Investigational Site
city: Besancon
country: France
facility: Pfizer Investigational Site
city: Beziers
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Bourg en Bresse
country: France
facility: Pfizer Investigational Site
city: Caen
country: France
facility: Pfizer Investigational Site
city: Cannes
country: France
facility: Pfizer Investigational Site
city: Castelsarrasin
country: France
facility: Pfizer Investigational Site
city: Chalon Sur Saone
country: France
facility: Pfizer Investigational Site
city: Chalons en Champagne
country: France
facility: Pfizer Investigational Site
city: Chamalieres-Royat
country: France
facility: Pfizer Investigational Site
city: Chambery
country: France
facility: Pfizer Investigational Site
city: Chartres
country: France
facility: Pfizer Investigational Site
city: Chassieu
country: France
facility: Pfizer Investigational Site
city: Chateau Renault
country: France
facility: Pfizer Investigational Site
city: Chateaudun
country: France
facility: Pfizer Investigational Site
city: Clamart
country: France
facility: Pfizer Investigational Site
city: Clermont Ferrand
country: France
facility: Pfizer Investigational Site
city: Clermont-Ferrand
country: France
facility: Pfizer Investigational Site
city: Colmar
country: France
facility: Pfizer Investigational Site
city: Coulommiers
country: France
facility: Pfizer Investigational Site
city: Dax
country: France
facility: Pfizer Investigational Site
city: Etampes
country: France
facility: Pfizer Investigational Site
city: Figeac
country: France
facility: Pfizer Investigational Site
city: Frejus
country: France
facility: Pfizer Investigational Site
city: Goussainville
country: France
facility: Pfizer Investigational Site
city: Haguenau
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: Jarny
country: France
facility: Pfizer Investigational Site
city: La Fleche
country: France
facility: Pfizer Investigational Site
city: Langon
country: France
facility: Pfizer Investigational Site
city: Lannion
country: France
facility: Pfizer Investigational Site
city: Le Mans
country: France
facility: Pfizer Investigational Site
city: Le Quesnoy
country: France
facility: Pfizer Investigational Site
city: Les Clayes Sous Bois
country: France
facility: Pfizer Investigational Site
city: Les Lilas
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Limoges
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: 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: Meaux
country: France
facility: Pfizer Investigational Site
city: Meudon
country: France
facility: Pfizer Investigational Site
city: Meyzieu
country: France
facility: Pfizer Investigational Site
city: Montargis
country: France
facility: Pfizer Investigational Site
city: Montbeliard
country: France
facility: Pfizer Investigational Site
city: Montigny Le Bretonneux
country: France
facility: Pfizer Investigational Site
city: Moulins
country: France
facility: Pfizer Investigational Site
city: Mulhouse
country: France
facility: Pfizer Investigational Site
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Nemours
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Noeux Les Mines
country: France
facility: Pfizer Investigational Site
city: Orleans
country: France
facility: Pfizer Investigational Site
city: Orsay
country: France
facility: Pfizer Investigational Site
city: Pantin
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: Pau
country: France
facility: Pfizer Investigational Site
city: Perpignan
country: France
facility: Pfizer Investigational Site
city: Poissy
country: France
facility: Pfizer Investigational Site
city: Quetigny
country: France
facility: Pfizer Investigational Site
city: Rillieux La Pape
country: France
facility: Pfizer Investigational Site
city: Roanne
country: France
facility: Pfizer Investigational Site
city: Roquebrune-Cap-Martin
country: France
facility: Pfizer Investigational Site
city: Roye
country: France
facility: Pfizer Investigational Site
city: Saint Laurent Du Var
country: France
facility: Pfizer Investigational Site
city: Saint Quentin
country: France
facility: Pfizer Investigational Site
city: Sainte-Maure-de-Touraine
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: Sceaux
country: France
facility: Pfizer Investigational Site
city: St. Girons
country: France
facility: Pfizer Investigational Site
city: St. Maur Des Fosses
country: France
facility: Pfizer Investigational Site
city: Toulon
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Tremblay en France
country: France
facility: Pfizer Investigational Site
city: Troyes
country: France
facility: Pfizer Investigational Site
city: Vauvert
country: France
facility: Pfizer Investigational Site
city: Vendome
country: France
facility: Pfizer Investigational Site
city: Versailles
country: France
facility: Pfizer Investigational Site
city: Viarmes
country: France
facility: Pfizer Investigational Site
city: Villeneuve la Garenne
country: France
facility: Pfizer Investigational Site
city: Villeparisis
country: France
facility: Pfizer Investigational Site
city: Villiers Le Bel
country: France
facility: Pfizer Investigational Site
city: Wasselonne
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.