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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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, 69001
        • Pfizer Investigational Site
      • Lyon, France, 69006
        • Pfizer Investigational Site
      • Lyon, France, 69009
        • Pfizer Investigational Site
      • Marseille, France, 13009
        • Pfizer Investigational Site
      • Marseille, France, 13004
        • Pfizer Investigational Site
      • Marseille, France, 13005
        • Pfizer Investigational Site
      • Marseille, France, 13008
        • 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, 75018
        • Pfizer Investigational Site
      • Paris, France, 75013
        • Pfizer Investigational Site
      • Paris, France, 75007
        • Pfizer Investigational Site
      • Paris, France, 75008
        • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
in the evening during 84 days
Other Names:
  • XALACOM
Other: Procedure
Procedure: GSS questionnaire
D0, D30 and D84
Procedure: IOP
D0, D30 and D84
Procedure: Visual acuity
D0 and D84

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute and relative IOP change after 4 and 12 weeks of treatment
Time Frame: week 4 and 12
week 4 and 12
Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,
Time Frame: week 12
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

October 3, 2005

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6641040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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