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

NCT ID: NCT00230763

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Glaucoma, Primary Open Angle (POAG) Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

Group Type EXPERIMENTAL

LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION

Intervention Type DRUG

in the evening during 84 days

Procedure

Group Type OTHER

GSS questionnaire

Intervention Type PROCEDURE

D0, D30 and D84

IOP

Intervention Type PROCEDURE

D0, D30 and D84

Visual acuity

Intervention Type PROCEDURE

D0 and D84

Interventions

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GSS questionnaire

D0, D30 and D84

Intervention Type PROCEDURE

IOP

D0, D30 and D84

Intervention Type PROCEDURE

LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION

in the evening during 84 days

Intervention Type DRUG

Visual acuity

D0 and D84

Intervention Type PROCEDURE

Other Intervention Names

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XALACOM

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Agen, , France

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Amboise, , France

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Amiens, , France

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Andrésy, , France

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Asnières-sur-Seine, , France

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Aubière, , France

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Aurillac, , France

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Belfort, , France

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Besançon, , France

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Béziers, , France

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Bordeaux, , France

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Bourg-en-Bresse, , France

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Caen, , France

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Cannes, , France

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Castelsarrasin, , France

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Chalon-sur-Saône, , France

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Chamalieres-Royat, , France

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Chambéry, , France

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Chartres, , France

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Chassieu, , France

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Châlons-en-Champagne, , France

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Château-Renault, , France

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Châteaudun, , France

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Clamart, , France

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Clermont-Ferrand, , France

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Clermont-Ferrand, , France

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Colmar, , France

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Coulommiers, , France

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Dax, , France

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Étampes, , France

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Figeac, , France

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Fréjus, , France

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Goussainville, , France

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Haguenau, , France

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Hyères, , France

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Issy-les-Moulineaux, , France

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Ivry-sur-Seine, , France

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Jarny, , France

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La Flèche, , France

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Langon, , France

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Lannion, , France

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Le Mans, , France

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Le Quesnoy, , France

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Les Clayes-sous-Bois, , France

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Les Lilas, , France

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Lille, , France

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Limoges, , France

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Luxeuil-les-Bains, , France

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Lyon, , France

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Lyon, , France

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Lyon, , France

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Marseille, , France

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Meaux, , France

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Meudon, , France

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Meyzieu, , France

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Montargis, , France

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Montbéliard, , France

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Montigny-le-Bretonneux, , France

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Moulins, , France

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Mulhouse, , France

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Nantes, , France

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Nemours, , France

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Nice, , France

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Nœux-les-Mines, , France

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Orléans, , France

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Orsay, , France

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Pantin, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pau, , France

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Perpignan, , France

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Poissy, , France

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Quetigny, , France

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Rillieux-la-Pape, , France

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Roanne, , France

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Roquebrune-Cap-Martin, , France

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Roye, , France

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Saint-Girons, , France

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Saint-Laurent-du-Var, , France

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Saint-Maur-des-Fossés, , France

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Saint-Quentin, , France

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Sainte-Maure-de-Touraine, , France

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Saintes, , France

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Salon-de-Provence, , France

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Sceaux, , France

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Toulon, , France

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Toulouse, , France

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Tremblay-en-France, , France

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Troyes, , France

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Vauvert, , France

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Vendôme, , France

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Versailles, , France

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Viarmes, , France

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Villeneuve-la-Garenne, , France

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Villeparisis, , France

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Villiers-le-Bel, , France

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Wasselonne, , France

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Countries

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France

References

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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.

Reference Type DERIVED
PMID: 20346127 (View on PubMed)

Related Links

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Other Identifiers

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A6641040

Identifier Type: -

Identifier Source: org_study_id

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