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

Primary Purpose

Glaucoma, Primary Open Angle (POAG), Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
GSS questionnaire
IOP
LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
Visual acuity
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Primary Open Angle (POAG)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Active

Procedure

Arm Description

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2005
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00230763
Brief Title
Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure
Acronym
PREDICOM
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle (POAG), Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Title
Procedure
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
GSS questionnaire
Intervention Description
D0, D30 and D84
Intervention Type
Procedure
Intervention Name(s)
IOP
Intervention Description
D0, D30 and D84
Intervention Type
Drug
Intervention Name(s)
LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
Other Intervention Name(s)
XALACOM
Intervention Description
in the evening during 84 days
Intervention Type
Procedure
Intervention Name(s)
Visual acuity
Intervention Description
D0 and D84
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Absolute and relative IOP change after 4 and 12 weeks of treatment
Time Frame
week 4 and 12
Title
Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Agen
ZIP/Postal Code
47000
Country
France
Facility Name
Pfizer Investigational Site
City
Amboise
ZIP/Postal Code
37400
Country
France
Facility Name
Pfizer Investigational Site
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
Pfizer Investigational Site
City
Andresy
ZIP/Postal Code
78570
Country
France
Facility Name
Pfizer Investigational Site
City
Asnieres Sur Seine
ZIP/Postal Code
92600
Country
France
Facility Name
Pfizer Investigational Site
City
Aubiere
ZIP/Postal Code
63170
Country
France
Facility Name
Pfizer Investigational Site
City
Aurillac
ZIP/Postal Code
15000
Country
France
Facility Name
Pfizer Investigational Site
City
Belfort
ZIP/Postal Code
90000
Country
France
Facility Name
Pfizer Investigational Site
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Pfizer Investigational Site
City
Beziers
ZIP/Postal Code
34500
Country
France
Facility Name
Pfizer Investigational Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Pfizer Investigational Site
City
Bourg en Bresse
ZIP/Postal Code
01000
Country
France
Facility Name
Pfizer Investigational Site
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Pfizer Investigational Site
City
Cannes
ZIP/Postal Code
06400
Country
France
Facility Name
Pfizer Investigational Site
City
Castelsarrasin
ZIP/Postal Code
82100
Country
France
Facility Name
Pfizer Investigational Site
City
Chalon Sur Saone
ZIP/Postal Code
71100
Country
France
Facility Name
Pfizer Investigational Site
City
Chalons en Champagne
ZIP/Postal Code
51000
Country
France
Facility Name
Pfizer Investigational Site
City
Chamalieres-Royat
ZIP/Postal Code
63400
Country
France
Facility Name
Pfizer Investigational Site
City
Chambery
ZIP/Postal Code
73000
Country
France
Facility Name
Pfizer Investigational Site
City
Chartres
ZIP/Postal Code
28000
Country
France
Facility Name
Pfizer Investigational Site
City
Chassieu
Country
France
Facility Name
Pfizer Investigational Site
City
Chateau Renault
ZIP/Postal Code
37110
Country
France
Facility Name
Pfizer Investigational Site
City
Chateaudun
ZIP/Postal Code
28200
Country
France
Facility Name
Pfizer Investigational Site
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont-Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
Pfizer Investigational Site
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Pfizer Investigational Site
City
Coulommiers
ZIP/Postal Code
77120
Country
France
Facility Name
Pfizer Investigational Site
City
Dax
ZIP/Postal Code
40100
Country
France
Facility Name
Pfizer Investigational Site
City
Etampes
ZIP/Postal Code
91150
Country
France
Facility Name
Pfizer Investigational Site
City
Figeac
ZIP/Postal Code
46100
Country
France
Facility Name
Pfizer Investigational Site
City
Frejus
ZIP/Postal Code
83600
Country
France
Facility Name
Pfizer Investigational Site
City
Goussainville
ZIP/Postal Code
95190
Country
France
Facility Name
Pfizer Investigational Site
City
Haguenau
ZIP/Postal Code
67500
Country
France
Facility Name
Pfizer Investigational Site
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Pfizer Investigational Site
City
Issy Les Moulineaux
ZIP/Postal Code
92130
Country
France
Facility Name
Pfizer Investigational Site
City
Ivry Sur Seine
ZIP/Postal Code
94200
Country
France
Facility Name
Pfizer Investigational Site
City
Jarny
ZIP/Postal Code
54800
Country
France
Facility Name
Pfizer Investigational Site
City
La Fleche
ZIP/Postal Code
72200
Country
France
Facility Name
Pfizer Investigational Site
City
Langon
ZIP/Postal Code
33210
Country
France
Facility Name
Pfizer Investigational Site
City
Lannion
ZIP/Postal Code
22300
Country
France
Facility Name
Pfizer Investigational Site
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Pfizer Investigational Site
City
Le Quesnoy
ZIP/Postal Code
59530
Country
France
Facility Name
Pfizer Investigational Site
City
Les Clayes Sous Bois
ZIP/Postal Code
78340
Country
France
Facility Name
Pfizer Investigational Site
City
Les Lilas
ZIP/Postal Code
93260
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Limoges
ZIP/Postal Code
87100
Country
France
Facility Name
Pfizer Investigational Site
City
Luxeuil Les Bains
ZIP/Postal Code
70300
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69001
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13004
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Pfizer Investigational Site
City
Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
Pfizer Investigational Site
City
Meudon
ZIP/Postal Code
921090
Country
France
Facility Name
Pfizer Investigational Site
City
Meyzieu
ZIP/Postal Code
69330
Country
France
Facility Name
Pfizer Investigational Site
City
Montargis
ZIP/Postal Code
45200
Country
France
Facility Name
Pfizer Investigational Site
City
Montbeliard
ZIP/Postal Code
25200
Country
France
Facility Name
Pfizer Investigational Site
City
Montigny Le Bretonneux
ZIP/Postal Code
78180
Country
France
Facility Name
Pfizer Investigational Site
City
Moulins
ZIP/Postal Code
03000
Country
France
Facility Name
Pfizer Investigational Site
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Pfizer Investigational Site
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Pfizer Investigational Site
City
Nemours
ZIP/Postal Code
77140
Country
France
Facility Name
Pfizer Investigational Site
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Pfizer Investigational Site
City
Noeux Les Mines
ZIP/Postal Code
62290
Country
France
Facility Name
Pfizer Investigational Site
City
Orleans
ZIP/Postal Code
08025
Country
France
Facility Name
Pfizer Investigational Site
City
Orsay
ZIP/Postal Code
91400
Country
France
Facility Name
Pfizer Investigational Site
City
Pantin
ZIP/Postal Code
93500
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75008
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Pfizer Investigational Site
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Pfizer Investigational Site
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Pfizer Investigational Site
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
Pfizer Investigational Site
City
Quetigny
ZIP/Postal Code
21800
Country
France
Facility Name
Pfizer Investigational Site
City
Rillieux La Pape
ZIP/Postal Code
69140
Country
France
Facility Name
Pfizer Investigational Site
City
Roanne
ZIP/Postal Code
42300
Country
France
Facility Name
Pfizer Investigational Site
City
Roquebrune-Cap-Martin
ZIP/Postal Code
06190
Country
France
Facility Name
Pfizer Investigational Site
City
Roye
ZIP/Postal Code
80700
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Laurent Du Var
ZIP/Postal Code
06700
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
Pfizer Investigational Site
City
Sainte-Maure-de-Touraine
ZIP/Postal Code
37800
Country
France
Facility Name
Pfizer Investigational Site
City
Saintes
ZIP/Postal Code
17100
Country
France
Facility Name
Pfizer Investigational Site
City
Salon De Provence
ZIP/Postal Code
13300
Country
France
Facility Name
Pfizer Investigational Site
City
Sceaux
ZIP/Postal Code
92330
Country
France
Facility Name
Pfizer Investigational Site
City
St. Girons
ZIP/Postal Code
09200
Country
France
Facility Name
Pfizer Investigational Site
City
St. Maur Des Fosses
ZIP/Postal Code
94100
Country
France
Facility Name
Pfizer Investigational Site
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Pfizer Investigational Site
City
Tremblay en France
ZIP/Postal Code
93290
Country
France
Facility Name
Pfizer Investigational Site
City
Troyes
ZIP/Postal Code
10000
Country
France
Facility Name
Pfizer Investigational Site
City
Vauvert
ZIP/Postal Code
30600
Country
France
Facility Name
Pfizer Investigational Site
City
Vendome
ZIP/Postal Code
41100
Country
France
Facility Name
Pfizer Investigational Site
City
Versailles
ZIP/Postal Code
78000
Country
France
Facility Name
Pfizer Investigational Site
City
Viarmes
ZIP/Postal Code
95270
Country
France
Facility Name
Pfizer Investigational Site
City
Villeneuve la Garenne
ZIP/Postal Code
92390
Country
France
Facility Name
Pfizer Investigational Site
City
Villeparisis
ZIP/Postal Code
77270
Country
France
Facility Name
Pfizer Investigational Site
City
Villiers Le Bel
ZIP/Postal Code
95400
Country
France
Facility Name
Pfizer Investigational Site
City
Wasselonne
ZIP/Postal Code
67310
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20346127
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6641040&StudyName=Determination%20Of%20Predictive%20Factors%20Allowing%20To%20An%20Additional%2010%25%20Reduction%20Of%20Intra-Ocular%20Pressure
Description
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Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure

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