Glaucoma, Primary Open Angle (POAG)Phase 3PREDICOMNCT00230763

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

A Phase 3 study testing GSS questionnaire, IOP and LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION in people with Glaucoma, Primary Open Angle (POAG) and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 102 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Primary Open Angle (POAG), Ocular Hypertension
What is being tested?: GSS questionnaire, IOP and LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 396 participants
Where: 102 sitesFrance
Study dates: Sep 2005to Oct 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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,

Who cannot join

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,

Trial locations and contacts

102 sites in 1 country.

City, postcode or hospital

102 sites in 1 country

France102 sites

Pfizer Investigational Site
Agen, 47000
Pfizer Investigational Site
Amboise, 37400
Pfizer Investigational Site
Amiens, 80000
Pfizer Investigational Site
Andrésy, 78570
Pfizer Investigational Site
Asnières-sur-Seine, 92600
Pfizer Investigational Site
Aubière, 63170
Pfizer Investigational Site
Aurillac, 15000
Pfizer Investigational Site
Belfort, 90000
Pfizer Investigational Site
Besançon, 25000
Pfizer Investigational Site
Béziers, 34500
Pfizer Investigational Site
Bordeaux, 33000
Pfizer Investigational Site
Bourg-en-Bresse, 01000
Pfizer Investigational Site
Caen, 14000
Pfizer Investigational Site
Cannes, 06400
Pfizer Investigational Site
Castelsarrasin, 82100
Pfizer Investigational Site
Chalon-sur-Saône, 71100
Pfizer Investigational Site
Châlons-en-Champagne, 51000
Pfizer Investigational Site
Chamalieres-Royat, 63400
Pfizer Investigational Site
Chambéry, 73000
Pfizer Investigational Site
Chartres, 28000
Pfizer Investigational Site
Chassieu
Pfizer Investigational Site
Château-Renault, 37110
Pfizer Investigational Site
Châteaudun, 28200
Pfizer Investigational Site
Clamart, 92140
Pfizer Investigational Site
Clermont-Ferrand, 63000
Pfizer Investigational Site
Clermont-Ferrand, 63100
Pfizer Investigational Site
Colmar, 68000
Pfizer Investigational Site
Coulommiers, 77120
Pfizer Investigational Site
Dax, 40100
Pfizer Investigational Site
Étampes, 91150
Pfizer Investigational Site
Figeac, 46100
Pfizer Investigational Site
Fréjus, 83600
Pfizer Investigational Site
Goussainville, 95190
Pfizer Investigational Site
Haguenau, 67500
Pfizer Investigational Site
Hyères, 83400
Pfizer Investigational Site
Issy-les-Moulineaux, 92130
Pfizer Investigational Site
Ivry-sur-Seine, 94200
Pfizer Investigational Site
Jarny, 54800
Pfizer Investigational Site
La Flèche, 72200
Pfizer Investigational Site
Langon, 33210
Pfizer Investigational Site
Lannion, 22300
Pfizer Investigational Site
Le Mans, 72000
Pfizer Investigational Site
Le Quesnoy, 59530
Pfizer Investigational Site
Les Clayes-sous-Bois, 78340
Pfizer Investigational Site
Les Lilas, 93260
Pfizer Investigational Site
Lille, 59037
Pfizer Investigational Site
Limoges, 87100
Pfizer Investigational Site
Luxeuil-les-Bains, 70300
Pfizer Investigational Site
Lyon, 69001
Pfizer Investigational Site
Lyon, 69006
Pfizer Investigational Site
Lyon, 69009
Pfizer Investigational Site
Marseille, 13004
Pfizer Investigational Site
Marseille, 13005
Pfizer Investigational Site
Marseille, 13008
Pfizer Investigational Site
Marseille, 13009
Pfizer Investigational Site
Meaux, 77100
Pfizer Investigational Site
Meudon, 921090
Pfizer Investigational Site
Meyzieu, 69330
Pfizer Investigational Site
Montargis, 45200
Pfizer Investigational Site
Montbéliard, 25200
Pfizer Investigational Site
Montigny-le-Bretonneux, 78180
Pfizer Investigational Site
Moulins, 03000
Pfizer Investigational Site
Mulhouse, 68100
Pfizer Investigational Site
Nantes, 44000
Pfizer Investigational Site
Nemours, 77140
Pfizer Investigational Site
Nice, 06000
Pfizer Investigational Site
Nœux-les-Mines, 62290
Pfizer Investigational Site
Orléans, 08025
Pfizer Investigational Site
Orsay, 91400
Pfizer Investigational Site
Pantin, 93500
Pfizer Investigational Site
Paris, 75007
Pfizer Investigational Site
Paris, 75008
Pfizer Investigational Site
Paris, 75013
Pfizer Investigational Site
Paris, 75018
Pfizer Investigational Site
Pau, 64000
Pfizer Investigational Site
Perpignan, 66000
Pfizer Investigational Site
Poissy, 78300
Pfizer Investigational Site
Quetigny, 21800
Pfizer Investigational Site
Rillieux-la-Pape, 69140
Pfizer Investigational Site
Roanne, 42300
Pfizer Investigational Site
Roquebrune-Cap-Martin, 06190
Pfizer Investigational Site
Roye, 80700
Pfizer Investigational Site
Saint-Girons, 09200
Pfizer Investigational Site
Saint-Laurent-du-Var, 06700
Pfizer Investigational Site
Saint-Maur-des-Fossés, 94100
Pfizer Investigational Site
Saint-Quentin, 02100
Pfizer Investigational Site
Sainte-Maure-de-Touraine, 37800
Pfizer Investigational Site
Saintes, 17100
Pfizer Investigational Site
Salon-de-Provence, 13300
Pfizer Investigational Site
Sceaux, 92330
Pfizer Investigational Site
Toulon, 83000
Pfizer Investigational Site
Toulouse, 31000
Pfizer Investigational Site
Tremblay-en-France, 93290
Pfizer Investigational Site
Troyes, 10000
Pfizer Investigational Site
Vauvert, 30600
Pfizer Investigational Site
Vendôme, 41100
Pfizer Investigational Site
Versailles, 78000
Pfizer Investigational Site
Viarmes, 95270
Pfizer Investigational Site
Villeneuve-la-Garenne, 92390
Pfizer Investigational Site
Villeparisis, 77270
Pfizer Investigational Site
Villiers-le-Bel, 95400
Pfizer Investigational Site
Wasselonne, 67310

Other trials in France

About this study

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

Conditions: Glaucoma, Primary Open Angle (POAG), Ocular Hypertension
Being tested: GSS questionnaire, IOP, LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION, Visual acuity
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSS questionnaireProcedure or surgery
D0, D30 and D84
IOPProcedure or surgery
D0, D30 and D84
LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATIONDrug
Also called XALACOM
in the evening during 84 days
Visual acuityProcedure or surgery
D0 and D84

Study groups in NCT00230763
Study group	Role	What they receive
Active	Experimental	Not described Receives: Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
Procedure	Other	Not described Receives: Procedure: GSS questionnaire; Procedure: IOP; Procedure: Visual acuity

What is being measured

The primary outcome is the main question the study is designed to answer.

A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
Measured: after 12 weeks of treatment

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Oct 2007

First posted3 Oct 2005 (estimated)
Study startSep 2005
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glaucoma, Primary Open Angle (POAG)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 396 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00230763
Sponsor's protocol ID: A6641040
Acronym: PREDICOM
Status last verified: Mar 2015
First submitted: 29 Sep 2005
Last updated: 18 Feb 2021
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 20346127

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
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RecruitingPhase 1/2
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
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RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
Not yet recruiting
Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
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All Glaucoma, Primary Open Angle (POAG) trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00230763
Acronym / sponsor ID: PREDICOM / A6641040
Conditions: Glaucoma, Primary Open Angle (POAG), Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 396 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 3 Oct 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Active	Experimental	Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
Procedure	Other	Procedure: GSS questionnaire, Procedure: IOP, Procedure: Visual acuity

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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,

Key exclusion criteria (4 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSS questionnaireD0, D30 and D84	Procedure or surgery	Procedure
IOPD0, D30 and D84	Procedure or surgery	Procedure
LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATIONAlso: XALACOMin the evening during 84 days	Drug	Active
Visual acuityD0 and D84	Procedure or surgery	Procedure

Primary outcome

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

2 secondary outcomes

Absolute and relative IOP change after 4 and 12 weeks of treatment
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Derived from this study: PubMed 20346127Sellem 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Glaucoma, Primary Open Angle (POAG)

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
RecruitingPhase 1/2
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT)
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
Not yet recruiting
Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
Primary Open Angle Glaucoma (POAG), Juvenile Open Angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

102 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00230763, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.