A Study to Assess the Efficacy of 3 Months of Latanoprost Treatment in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-angle Glaucoma

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg

The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 4

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
      • Albi, France, 81000
        • Pfizer Investigational Site
      • Ambert, France, 63600
        • Pfizer Investigational Site
      • Amboise, France, 37400
        • Pfizer Investigational Site
      • Angers, France, 49100
        • Pfizer Investigational Site
      • Antibes, France, 06600
        • Pfizer Investigational Site
      • Aubenas, France, 07200
        • Pfizer Investigational Site
      • Belfort, France, 90000
        • Pfizer Investigational Site
      • Bergerac, France, 24100
        • Pfizer Investigational Site
      • Bernay, France, 27300
        • Pfizer Investigational Site
      • Bethune, France, 62400
        • Pfizer Investigational Site
      • Beziers, France, 34500
        • Pfizer Investigational Site
      • Blagnac, France, 31700
        • Pfizer Investigational Site
      • Bordeaux, France, 33000
        • Pfizer Investigational Site
      • Bordeaux, France, 33100
        • Pfizer Investigational Site
      • Bougival, France, 78380
        • Pfizer Investigational Site
      • Boulogne-Billancourt, France, 92100
        • Pfizer Investigational Site
      • Brest, France, 29200
        • Pfizer Investigational Site
      • Bry Sur Marne, France, 94360
        • Pfizer Investigational Site
      • Carentan, France, 50500
        • Pfizer Investigational Site
      • Cenon, France, 33150
        • Pfizer Investigational Site
      • Chamalieres, France, 63400
        • Pfizer Investigational Site
      • Chantilly, France, 60500
        • Pfizer Investigational Site
      • Chartres, France, 28000
        • Pfizer Investigational Site
      • Chateaubriant, France, 44110
        • Pfizer Investigational Site
      • Chateaulin, France, 29150
        • Pfizer Investigational Site
      • Clermont-Ferrand, France, 63100
        • Pfizer Investigational Site
      • Condom, France, 32100
        • Pfizer Investigational Site
      • Coulommiers, France, 77120
        • Pfizer Investigational Site
      • Courbevoie, France, 92400
        • Pfizer Investigational Site
      • Creil, France, 60100
        • Pfizer Investigational Site
      • Deauville, France, 14800
        • Pfizer Investigational Site
      • Deuil la Barre, France, 95170
        • Pfizer Investigational Site
      • Douai, France, 59500
        • Pfizer Investigational Site
      • Draveil, France, 91210
        • Pfizer Investigational Site
      • Enghien Les Bains, France, 95880
        • Pfizer Investigational Site
      • Epernay, France, 51200
        • Pfizer Investigational Site
      • Fontaine, France, 38600
        • Pfizer Investigational Site
      • Frejus, France, 83600
        • Pfizer Investigational Site
      • Gennevilliers, France, 92230
        • Pfizer Investigational Site
      • Gradignan, France, 33170
        • Pfizer Investigational Site
      • Grasse, France, 06130
        • Pfizer Investigational Site
      • Grasse, France, 06135
        • Pfizer Investigational Site
      • Grenoble, France, 38100
        • Pfizer Investigational Site
      • Grenoble, France, 38000
        • Pfizer Investigational Site
      • Guingamp, France, 22200
        • Pfizer Investigational Site
      • Haguenau, France, 67500
        • Pfizer Investigational Site
      • Herblay, France, 95220
        • Pfizer Investigational Site
      • Hyeres, France, 83400
        • Pfizer Investigational Site
      • Issy Les Moulineaux, France, 92130
        • Pfizer Investigational Site
      • Ivry Sur Seine, France, 94210
        • Pfizer Investigational Site
      • Jarville La Malgrange, France, 5414
        • Pfizer Investigational Site
      • Joigny, France, 89300
        • Pfizer Investigational Site
      • Juvisy Sur Orge, France, 91260
        • Pfizer Investigational Site
      • La Rochelle, France, 17000
        • Pfizer Investigational Site
      • La Talaudiere, France, 42350
        • Pfizer Investigational Site
      • La Trinite, France, 06340
        • Pfizer Investigational Site
      • Landerneau, France, 29800
        • Pfizer Investigational Site
      • Langon, France, 33210
        • Pfizer Investigational Site
      • Lannion, France, 22300
        • Pfizer Investigational Site
      • Laon, France, 02000
        • Pfizer Investigational Site
      • Le Creuzot, France, 71200
        • Pfizer Investigational Site
      • Le Havre, France, 76600
        • Pfizer Investigational Site
      • Le Mans, France, 72000
        • Pfizer Investigational Site
      • Le Peage De Rousillon, France, 38550
        • Pfizer Investigational Site
      • Le Quesnoy, France, 59530
        • Pfizer Investigational Site
      • Lesneven, France, 29260
        • Pfizer Investigational Site
      • Lille, France, 59000
        • Pfizer Investigational Site
      • Livry Gargan, France, 93190
        • Pfizer Investigational Site
      • Lunel, France, 34400
        • Pfizer Investigational Site
      • Luneville, France, 54300
        • Pfizer Investigational Site
      • Luxeuil les Bains, France, 70300
        • Pfizer Investigational Site
      • Lyon, France, 69437
        • Pfizer Investigational Site
      • Lyon, France, 69006
        • Pfizer Investigational Site
      • Lyon, France, 69008
        • Pfizer Investigational Site
      • Lyon, France, 69002
        • Pfizer Investigational Site
      • MArseille, France, 13009
        • Pfizer Investigational Site
      • Maisons Laffitte, France, 78600
        • Pfizer Investigational Site
      • Marcq en Baroeul, France, 59700
        • Pfizer Investigational Site
      • Marignanne, France, 13700
        • Pfizer Investigational Site
      • Marseille, France, 13004
        • Pfizer Investigational Site
      • Marseille, France, 13008
        • Pfizer Investigational Site
      • Marseille, France, 13012
        • Pfizer Investigational Site
      • Marseille, France, 13001
        • Pfizer Investigational Site
      • Meyzieu, France, 69330
        • Pfizer Investigational Site
      • Montauban, France, 82000
        • Pfizer Investigational Site
      • Montceau Les Mines, France, 71300
        • Pfizer Investigational Site
      • Montpellier, France, 34000
        • Pfizer Investigational Site
      • Mulhouse, France, 68200
        • Pfizer Investigational Site
      • Nantes, France, 44000
        • Pfizer Investigational Site
      • Nice, France, 06000
        • Pfizer Investigational Site
      • Nice, France, 06300
        • Pfizer Investigational Site
      • Nimes, France, 30000
        • Pfizer Investigational Site
      • Nimes Cedex 2, France, 30918
        • Pfizer Investigational Site
      • Niort, France, 79000
        • Pfizer Investigational Site
      • Nogent Sur Marne, France, 94130
        • Pfizer Investigational Site
      • Noyon, France, 60400
        • Pfizer Investigational Site
      • Orleans, France, 45000
        • Pfizer Investigational Site
      • Oullins, France, 69600
        • Pfizer Investigational Site
      • Pantin, France, 93500
        • Pfizer Investigational Site
      • Paray le Monial, France, 71600
        • Pfizer Investigational Site
      • Paris, France, 75015
        • Pfizer Investigational Site
      • Paris, France, 75019
        • Pfizer Investigational Site
      • Paris, France, 75020
        • Pfizer Investigational Site
      • Paris, France, 75018
        • Pfizer Investigational Site
      • Paris, France, 75013
        • Pfizer Investigational Site
      • Paris, France, 75014
        • Pfizer Investigational Site
      • Paris, France, 75008
        • Pfizer Investigational Site
      • Paris, France, 75012
        • Pfizer Investigational Site
      • Paris, France, 75016
        • Pfizer Investigational Site
      • Paris, France, 75006
        • Pfizer Investigational Site
      • Paris, France, 75010
        • Pfizer Investigational Site
      • Paris, France, 75009
        • Pfizer Investigational Site
      • Paris, France, 75116
        • Pfizer Investigational Site
      • Pau, France, 64000
        • Pfizer Investigational Site
      • Pauillac, France, 33250
        • Pfizer Investigational Site
      • Perigueux, France, 24000
        • Pfizer Investigational Site
      • Perros Girec, France, 22700
        • Pfizer Investigational Site
      • Pezenas, France, 34120
        • Pfizer Investigational Site
      • Poissy, France, 78300
        • Pfizer Investigational Site
      • Poitiers, France, 86000
        • Pfizer Investigational Site
      • Pont de Cheruy, France, 38230
        • Pfizer Investigational Site
      • Pornic, France, 44210
        • Pfizer Investigational Site
      • Port De Bouc, France, 13110
        • Pfizer Investigational Site
      • Quimper, France, 29000
        • Pfizer Investigational Site
      • Reims, France, 51100
        • Pfizer Investigational Site
      • Rochefort, France, 17300
        • Pfizer Investigational Site
      • Romilly sur Seine, France, 10100
        • Pfizer Investigational Site
      • Saint Die des Vosges, France, 88100
        • Pfizer Investigational Site
      • Saint Etienne, France, 42000
        • Pfizer Investigational Site
      • Saint Gaudens, France, 31800
        • Pfizer Investigational Site
      • Saint Savine, France, 10300
        • Pfizer Investigational Site
      • Saintes, France, 17100
        • Pfizer Investigational Site
      • Salon de Provence, France, 13300
        • Pfizer Investigational Site
      • Sartrouville, France, 78500
        • Pfizer Investigational Site
      • Sens, France, 89100
        • Pfizer Investigational Site
      • Sessiney Pariset, France, 38170
        • Pfizer Investigational Site
      • Sete, France, 34200
        • Pfizer Investigational Site
      • Soissons, France, 02209
        • Pfizer Investigational Site
      • St Chamond, France, 42200
        • Pfizer Investigational Site
      • St Etienne, France, 42100
        • Pfizer Investigational Site
      • St Michel Sur Orge, France, 91240
        • Pfizer Investigational Site
      • St. Brieuc, France, 22015
        • Pfizer Investigational Site
      • St. Lo, France, 50000
        • Pfizer Investigational Site
      • Strasbourg, France, 67000
        • Pfizer Investigational Site
      • Strasbourg, France, 67200
        • Pfizer Investigational Site
      • Suresnes, France, 92150
        • Pfizer Investigational Site
      • Talence, France, 33400
        • Pfizer Investigational Site
      • Thiers, France, 63300
        • Pfizer Investigational Site
      • Toulon, France, 83000
        • Pfizer Investigational Site
      • Toulouse, France, 31500
        • Pfizer Investigational Site
      • Toulouse, France, 34100
        • Pfizer Investigational Site
      • Tourcoing, France, 59200
        • Pfizer Investigational Site
      • Tournefeuille, France, 31170
        • Pfizer Investigational Site
      • Tours, France, 37000
        • Pfizer Investigational Site
      • Trelissac, France, 24750
        • Pfizer Investigational Site
      • Tremblay en France, France, 93290
        • Pfizer Investigational Site
      • Triel Sur Seine, France, 78510
        • Pfizer Investigational Site
      • Troyes, France, 10000
        • Pfizer Investigational Site
      • Valenciennes, France, 59300
        • Pfizer Investigational Site
      • Vannes, France, 56000
        • Pfizer Investigational Site
      • Vauvert, France, 30600
        • Pfizer Investigational Site
      • Veauche, France, 42340
        • Pfizer Investigational Site
      • Velaux, France, 13800
        • Pfizer Investigational Site
      • Vendargues, France, 34740
        • Pfizer Investigational Site
      • Venissieux Cedex, France, 69694
        • Pfizer Investigational Site
      • Viarmes, France, 95270
        • Pfizer Investigational Site
      • Vienne, France, 38200
        • Pfizer Investigational Site
      • Villeneuve D'Ascq, France, 59650
        • Pfizer Investigational Site
      • Villeneuve Saint Georges, France, 94190
        • Pfizer Investigational Site
      • Villeneuve la Garenne, France, 92390
        • Pfizer Investigational Site
      • Villeparisis, France, 77270
        • Pfizer Investigational Site
      • Villepinte, France, 93420
        • Pfizer Investigational Site
      • Villiers Le Bel, France, 95400
        • Pfizer Investigational Site
      • Vizille, France, 38220
        • Pfizer Investigational Site
      • Voiron, France, 38500
        • Pfizer Investigational Site
      • Wattrelos, France, 59150
        • 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:

  • A patient with an IOP greater than or equal to 20 mmHg related to unilateral or bilateral OH or OAG (primary open angle glaucoma, pseudo-exfoliative glaucoma, and pigmentary glaucoma), after a visual field exam
  • Naive patients (i.e. never having been treated) and requiring treatment initiation

Exclusion Criteria:

  • A patient with OH or OAG currently on treatment
  • A patient with OH or OAG previously treated (regardless of the date treatment was discontinued)
  • A patient with traumatic, inflammatory, or neovascular glaucoma

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Latanoprost group
Drug: Latanoprost
Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP
Time Frame: 3 months
3 months
Proportion of patients after 3 months of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%
Time Frame: 3 months
3 months
Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP
Time Frame: 1 month
1 month
Proportion of patients after 1 month of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%
Time Frame: 1 month
1 month
Proportion of patients after 3 months of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg
Time Frame: 3 months
3 months
Proportion of patients after 1 month of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg
Time Frame: 1 month
1 month
Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam
Time Frame: 3 months
3 months

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

December 1, 2003

Study Completion (ACTUAL)

February 1, 2005

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (ESTIMATE)

March 31, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6111002
  • X-FIL

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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