Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure (PREDICOM)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00230763
First received: September 29, 2005
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

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).


Condition Intervention Phase
Glaucoma, Primary Open Angle (POAG)
Ocular Hypertension
Procedure: GSS questionnaire
Procedure: IOP
Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
Procedure: Visual acuity
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population. [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute and relative IOP change after 4 and 12 weeks of treatment [ Time Frame: week 4 and 12 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment, [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Enrollment: 396
Study Start Date: September 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
in the evening during 84 days
Other Name: XALACOM
Procedure Procedure: GSS questionnaire
D0, D30 and D84
Procedure: IOP
D0, D30 and D84
Procedure: Visual acuity
D0 and D84

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230763

  Hide Study Locations
Locations
France
Pfizer Investigational Site
Agen, France, 47000
Pfizer Investigational Site
Amboise, France, 37400
Pfizer Investigational Site
Amiens, France, 80000
Pfizer Investigational Site
Andresy, France, 78570
Pfizer Investigational Site
Asnieres Sur Seine, France, 92600
Pfizer Investigational Site
Aubiere, France, 63170
Pfizer Investigational Site
Aurillac, France, 15000
Pfizer Investigational Site
Belfort, France, 90000
Pfizer Investigational Site
Besancon, France, 25000
Pfizer Investigational Site
Beziers, France, 34500
Pfizer Investigational Site
Bordeaux, France, 33000
Pfizer Investigational Site
Bourg en Bresse, France, 01000
Pfizer Investigational Site
Caen, France, 14000
Pfizer Investigational Site
Cannes, France, 06400
Pfizer Investigational Site
Castelsarrasin, France, 82100
Pfizer Investigational Site
Chalon Sur Saone, France, 71100
Pfizer Investigational Site
Chalons en Champagne, France, 51000
Pfizer Investigational Site
Chamalieres-Royat, France, 63400
Pfizer Investigational Site
Chambery, France, 73000
Pfizer Investigational Site
Chartres, France, 28000
Pfizer Investigational Site
Chassieu, France
Pfizer Investigational Site
Chateau Renault, France, 37110
Pfizer Investigational Site
Chateaudun, France, 28200
Pfizer Investigational Site
Clamart, France, 92140
Pfizer Investigational Site
Clermont Ferrand, France, 63000
Pfizer Investigational Site
Clermont-Ferrand, France, 63100
Pfizer Investigational Site
Colmar, France, 68000
Pfizer Investigational Site
Coulommiers, France, 77120
Pfizer Investigational Site
Dax, France, 40100
Pfizer Investigational Site
Etampes, France, 91150
Pfizer Investigational Site
Figeac, France, 46100
Pfizer Investigational Site
Frejus, France, 83600
Pfizer Investigational Site
Goussainville, France, 95190
Pfizer Investigational Site
Haguenau, France, 67500
Pfizer Investigational Site
Hyeres, France, 83400
Pfizer Investigational Site
Issy Les Moulineaux, France, 92130
Pfizer Investigational Site
Ivry Sur Seine, France, 94200
Pfizer Investigational Site
Jarny, France, 54800
Pfizer Investigational Site
La Fleche, France, 72200
Pfizer Investigational Site
Langon, France, 33210
Pfizer Investigational Site
Lannion, France, 22300
Pfizer Investigational Site
Le Mans, France, 72000
Pfizer Investigational Site
Le Quesnoy, France, 59530
Pfizer Investigational Site
Les Clayes Sous Bois, France, 78340
Pfizer Investigational Site
Les Lilas, France, 93260
Pfizer Investigational Site
Lille, France, 59037
Pfizer Investigational Site
Limoges, France, 87100
Pfizer Investigational Site
Luxeuil Les Bains, France, 70300
Pfizer Investigational Site
Lyon, France, 69006
Pfizer Investigational Site
Lyon, France, 69001
Pfizer Investigational Site
Lyon, France, 69009
Pfizer Investigational Site
Marseille, France, 13008
Pfizer Investigational Site
Marseille, France, 13009
Pfizer Investigational Site
Marseille, France, 13004
Pfizer Investigational Site
Marseille, France, 13005
Pfizer Investigational Site
Meaux, France, 77100
Pfizer Investigational Site
Meudon, France, 921090
Pfizer Investigational Site
Meyzieu, France, 69330
Pfizer Investigational Site
Montargis, France, 45200
Pfizer Investigational Site
Montbeliard, France, 25200
Pfizer Investigational Site
Montigny Le Bretonneux, France, 78180
Pfizer Investigational Site
Moulins, France, 03000
Pfizer Investigational Site
Mulhouse, France, 68100
Pfizer Investigational Site
Nantes, France, 44000
Pfizer Investigational Site
Nemours, France, 77140
Pfizer Investigational Site
Nice, France, 06000
Pfizer Investigational Site
Noeux Les Mines, France, 62290
Pfizer Investigational Site
Orleans, France, 08025
Pfizer Investigational Site
Orsay, France, 91400
Pfizer Investigational Site
Pantin, France, 93500
Pfizer Investigational Site
Paris, France, 75008
Pfizer Investigational Site
Paris, France, 75007
Pfizer Investigational Site
Paris, France, 75013
Pfizer Investigational Site
Paris, France, 75018
Pfizer Investigational Site
Pau, France, 64000
Pfizer Investigational Site
Perpignan, France, 66000
Pfizer Investigational Site
Poissy, France, 78300
Pfizer Investigational Site
Quetigny, France, 21800
Pfizer Investigational Site
Rillieux La Pape, France, 69140
Pfizer Investigational Site
Roanne, France, 42300
Pfizer Investigational Site
Roquebrune-Cap-Martin, France, 06190
Pfizer Investigational Site
Roye, France, 80700
Pfizer Investigational Site
Saint Laurent Du Var, France, 06700
Pfizer Investigational Site
Saint Quentin, France, 02100
Pfizer Investigational Site
Sainte-Maure-de-Touraine, France, 37800
Pfizer Investigational Site
Saintes, France, 17100
Pfizer Investigational Site
Salon De Provence, France, 13300
Pfizer Investigational Site
Sceaux, France, 92330
Pfizer Investigational Site
St. Girons, France, 09200
Pfizer Investigational Site
St. Maur Des Fosses, France, 94100
Pfizer Investigational Site
Toulon, France, 83000
Pfizer Investigational Site
Toulouse, France, 31000
Pfizer Investigational Site
Tremblay en France, France, 93290
Pfizer Investigational Site
Troyes, France, 10000
Pfizer Investigational Site
Vauvert, France, 30600
Pfizer Investigational Site
Vendome, France, 41100
Pfizer Investigational Site
Versailles, France, 78000
Pfizer Investigational Site
Viarmes, France, 95270
Pfizer Investigational Site
Villeneuve la Garenne, France, 92390
Pfizer Investigational Site
Villeparisis, France, 77270
Pfizer Investigational Site
Villiers Le Bel, France, 95400
Pfizer Investigational Site
Wasselonne, France, 67310
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00230763     History of Changes
Other Study ID Numbers: A6641040
Study First Received: September 29, 2005
Last Updated: October 14, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Latanoprost
Timolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014