Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure
PREDICOM
1 other identifier
interventional
396
1 country
102
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2005
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 29, 2005
CompletedFirst Posted
Study publicly available on registry
October 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFebruary 18, 2021
March 1, 2015
2.1 years
September 29, 2005
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
after 12 weeks of treatment
Secondary Outcomes (2)
Absolute and relative IOP change after 4 and 12 weeks of treatment
week 4 and 12
Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,
week 12
Study Arms (2)
Active
EXPERIMENTALProcedure
OTHERInterventions
in the evening during 84 days
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (102)
Pfizer Investigational Site
Agen, 47000, France
Pfizer Investigational Site
Amboise, 37400, France
Pfizer Investigational Site
Amiens, 80000, France
Pfizer Investigational Site
Andrésy, 78570, France
Pfizer Investigational Site
Asnières-sur-Seine, 92600, France
Pfizer Investigational Site
Aubière, 63170, France
Pfizer Investigational Site
Aurillac, 15000, France
Pfizer Investigational Site
Belfort, 90000, France
Pfizer Investigational Site
Besançon, 25000, France
Pfizer Investigational Site
Béziers, 34500, France
Pfizer Investigational Site
Bordeaux, 33000, France
Pfizer Investigational Site
Bourg-en-Bresse, 01000, France
Pfizer Investigational Site
Caen, 14000, France
Pfizer Investigational Site
Cannes, 06400, France
Pfizer Investigational Site
Castelsarrasin, 82100, France
Pfizer Investigational Site
Chalon-sur-Saône, 71100, France
Pfizer Investigational Site
Chamalieres-Royat, 63400, France
Pfizer Investigational Site
Chambéry, 73000, France
Pfizer Investigational Site
Chartres, 28000, France
Pfizer Investigational Site
Chassieu, France
Pfizer Investigational Site
Châlons-en-Champagne, 51000, France
Pfizer Investigational Site
Château-Renault, 37110, France
Pfizer Investigational Site
Châteaudun, 28200, France
Pfizer Investigational Site
Clamart, 92140, France
Pfizer Investigational Site
Clermont-Ferrand, 63000, France
Pfizer Investigational Site
Clermont-Ferrand, 63100, France
Pfizer Investigational Site
Colmar, 68000, France
Pfizer Investigational Site
Coulommiers, 77120, France
Pfizer Investigational Site
Dax, 40100, France
Pfizer Investigational Site
Étampes, 91150, France
Pfizer Investigational Site
Figeac, 46100, France
Pfizer Investigational Site
Fréjus, 83600, France
Pfizer Investigational Site
Goussainville, 95190, France
Pfizer Investigational Site
Haguenau, 67500, France
Pfizer Investigational Site
Hyères, 83400, France
Pfizer Investigational Site
Issy-les-Moulineaux, 92130, France
Pfizer Investigational Site
Ivry-sur-Seine, 94200, France
Pfizer Investigational Site
Jarny, 54800, France
Pfizer Investigational Site
La Flèche, 72200, France
Pfizer Investigational Site
Langon, 33210, France
Pfizer Investigational Site
Lannion, 22300, France
Pfizer Investigational Site
Le Mans, 72000, France
Pfizer Investigational Site
Le Quesnoy, 59530, France
Pfizer Investigational Site
Les Clayes-sous-Bois, 78340, France
Pfizer Investigational Site
Les Lilas, 93260, France
Pfizer Investigational Site
Lille, 59037, France
Pfizer Investigational Site
Limoges, 87100, France
Pfizer Investigational Site
Luxeuil-les-Bains, 70300, France
Pfizer Investigational Site
Lyon, 69001, France
Pfizer Investigational Site
Lyon, 69006, France
Pfizer Investigational Site
Lyon, 69009, France
Pfizer Investigational Site
Marseille, 13004, France
Pfizer Investigational Site
Marseille, 13005, France
Pfizer Investigational Site
Marseille, 13008, France
Pfizer Investigational Site
Marseille, 13009, France
Pfizer Investigational Site
Meaux, 77100, France
Pfizer Investigational Site
Meudon, 921090, France
Pfizer Investigational Site
Meyzieu, 69330, France
Pfizer Investigational Site
Montargis, 45200, France
Pfizer Investigational Site
Montbéliard, 25200, France
Pfizer Investigational Site
Montigny-le-Bretonneux, 78180, France
Pfizer Investigational Site
Moulins, 03000, France
Pfizer Investigational Site
Mulhouse, 68100, France
Pfizer Investigational Site
Nantes, 44000, France
Pfizer Investigational Site
Nemours, 77140, France
Pfizer Investigational Site
Nice, 06000, France
Pfizer Investigational Site
Nœux-les-Mines, 62290, France
Pfizer Investigational Site
Orléans, 08025, France
Pfizer Investigational Site
Orsay, 91400, France
Pfizer Investigational Site
Pantin, 93500, France
Pfizer Investigational Site
Paris, 75007, France
Pfizer Investigational Site
Paris, 75008, France
Pfizer Investigational Site
Paris, 75013, France
Pfizer Investigational Site
Paris, 75018, France
Pfizer Investigational Site
Pau, 64000, France
Pfizer Investigational Site
Perpignan, 66000, France
Pfizer Investigational Site
Poissy, 78300, France
Pfizer Investigational Site
Quetigny, 21800, France
Pfizer Investigational Site
Rillieux-la-Pape, 69140, France
Pfizer Investigational Site
Roanne, 42300, France
Pfizer Investigational Site
Roquebrune-Cap-Martin, 06190, France
Pfizer Investigational Site
Roye, 80700, France
Pfizer Investigational Site
Saint-Girons, 09200, France
Pfizer Investigational Site
Saint-Laurent-du-Var, 06700, France
Pfizer Investigational Site
Saint-Maur-des-Fossés, 94100, France
Pfizer Investigational Site
Saint-Quentin, 02100, France
Pfizer Investigational Site
Sainte-Maure-de-Touraine, 37800, France
Pfizer Investigational Site
Saintes, 17100, France
Pfizer Investigational Site
Salon-de-Provence, 13300, France
Pfizer Investigational Site
Sceaux, 92330, France
Pfizer Investigational Site
Toulon, 83000, France
Pfizer Investigational Site
Toulouse, 31000, France
Pfizer Investigational Site
Tremblay-en-France, 93290, France
Pfizer Investigational Site
Troyes, 10000, France
Pfizer Investigational Site
Vauvert, 30600, France
Pfizer Investigational Site
Vendôme, 41100, France
Pfizer Investigational Site
Versailles, 78000, France
Pfizer Investigational Site
Viarmes, 95270, France
Pfizer Investigational Site
Villeneuve-la-Garenne, 92390, France
Pfizer Investigational Site
Villeparisis, 77270, France
Pfizer Investigational Site
Villiers-le-Bel, 95400, France
Pfizer Investigational Site
Wasselonne, 67310, France
Related Publications (1)
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.
PMID: 20346127DERIVED
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 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2005
First Posted
October 3, 2005
Study Start
September 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
February 18, 2021
Record last verified: 2015-03