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NCT00647101 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00647101
Other study ID # A6111002
Secondary ID X-FIL
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2003
Est. completion date February 2005

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Latanoprost
Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months

Locations
Country Name City State
France Pfizer Investigational Site Albi
France Pfizer Investigational Site Ambert
France Pfizer Investigational Site Amboise
France Pfizer Investigational Site Angers
France Pfizer Investigational Site Antibes
France Pfizer Investigational Site Aubenas
France Pfizer Investigational Site Belfort
France Pfizer Investigational Site Bergerac
France Pfizer Investigational Site Bernay
France Pfizer Investigational Site Bethune
France Pfizer Investigational Site Beziers
France Pfizer Investigational Site Blagnac
France Pfizer Investigational Site Bordeaux
France Pfizer Investigational Site Bordeaux
France Pfizer Investigational Site Bougival
France Pfizer Investigational Site Boulogne-Billancourt
France Pfizer Investigational Site Brest
France Pfizer Investigational Site Bry Sur Marne
France Pfizer Investigational Site Carentan
France Pfizer Investigational Site Cenon
France Pfizer Investigational Site Chamalieres
France Pfizer Investigational Site Chantilly
France Pfizer Investigational Site Chartres
France Pfizer Investigational Site Chateaubriant
France Pfizer Investigational Site Chateaulin
France Pfizer Investigational Site Clermont-Ferrand
France Pfizer Investigational Site Condom
France Pfizer Investigational Site Coulommiers
France Pfizer Investigational Site Courbevoie
France Pfizer Investigational Site Creil
France Pfizer Investigational Site Deauville
France Pfizer Investigational Site Deuil la Barre
France Pfizer Investigational Site Douai
France Pfizer Investigational Site Draveil
France Pfizer Investigational Site Enghien Les Bains
France Pfizer Investigational Site Epernay
France Pfizer Investigational Site Fontaine
France Pfizer Investigational Site Frejus
France Pfizer Investigational Site Gennevilliers
France Pfizer Investigational Site Gradignan
France Pfizer Investigational Site Grasse
France Pfizer Investigational Site Grasse
France Pfizer Investigational Site Grenoble
France Pfizer Investigational Site Grenoble
France Pfizer Investigational Site Guingamp
France Pfizer Investigational Site Haguenau
France Pfizer Investigational Site Herblay
France Pfizer Investigational Site Hyeres
France Pfizer Investigational Site Issy Les Moulineaux
France Pfizer Investigational Site Ivry Sur Seine
France Pfizer Investigational Site Jarville La Malgrange
France Pfizer Investigational Site Joigny
France Pfizer Investigational Site Juvisy Sur Orge
France Pfizer Investigational Site La Rochelle
France Pfizer Investigational Site La Talaudiere
France Pfizer Investigational Site La Trinite
France Pfizer Investigational Site Landerneau
France Pfizer Investigational Site Langon
France Pfizer Investigational Site Lannion
France Pfizer Investigational Site Laon
France Pfizer Investigational Site Le Creuzot
France Pfizer Investigational Site Le Havre
France Pfizer Investigational Site Le Mans
France Pfizer Investigational Site Le Peage De Rousillon
France Pfizer Investigational Site Le Quesnoy
France Pfizer Investigational Site Lesneven
France Pfizer Investigational Site Lille
France Pfizer Investigational Site Livry Gargan
France Pfizer Investigational Site Lunel
France Pfizer Investigational Site Luneville
France Pfizer Investigational Site Luxeuil les Bains
France Pfizer Investigational Site Lyon
France Pfizer Investigational Site Lyon
France Pfizer Investigational Site Lyon
France Pfizer Investigational Site Lyon
France Pfizer Investigational Site Maisons Laffitte
France Pfizer Investigational Site Marcq en Baroeul
France Pfizer Investigational Site Marignanne
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site MArseille
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Meyzieu
France Pfizer Investigational Site Montauban
France Pfizer Investigational Site Montceau Les Mines
France Pfizer Investigational Site Montpellier
France Pfizer Investigational Site Mulhouse
France Pfizer Investigational Site Nantes
France Pfizer Investigational Site Nice
France Pfizer Investigational Site Nice
France Pfizer Investigational Site Nimes
France Pfizer Investigational Site Nimes Cedex 2
France Pfizer Investigational Site Niort
France Pfizer Investigational Site Nogent Sur Marne
France Pfizer Investigational Site Noyon
France Pfizer Investigational Site Orleans
France Pfizer Investigational Site Oullins
France Pfizer Investigational Site Pantin
France Pfizer Investigational Site Paray le Monial
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Pau
France Pfizer Investigational Site Pauillac
France Pfizer Investigational Site Perigueux
France Pfizer Investigational Site Perros Girec
France Pfizer Investigational Site Pezenas
France Pfizer Investigational Site Poissy
France Pfizer Investigational Site Poitiers
France Pfizer Investigational Site Pont de Cheruy
France Pfizer Investigational Site Pornic
France Pfizer Investigational Site Port De Bouc
France Pfizer Investigational Site Quimper
France Pfizer Investigational Site Reims
France Pfizer Investigational Site Rochefort
France Pfizer Investigational Site Romilly sur Seine
France Pfizer Investigational Site Saint Die des Vosges
France Pfizer Investigational Site Saint Etienne
France Pfizer Investigational Site Saint Gaudens
France Pfizer Investigational Site Saint Savine
France Pfizer Investigational Site Saintes
France Pfizer Investigational Site Salon de Provence
France Pfizer Investigational Site Sartrouville
France Pfizer Investigational Site Sens
France Pfizer Investigational Site Sessiney Pariset
France Pfizer Investigational Site Sete
France Pfizer Investigational Site Soissons
France Pfizer Investigational Site St Chamond
France Pfizer Investigational Site St Etienne
France Pfizer Investigational Site St Michel Sur Orge
France Pfizer Investigational Site St. Brieuc
France Pfizer Investigational Site St. Lo
France Pfizer Investigational Site Strasbourg
France Pfizer Investigational Site Strasbourg
France Pfizer Investigational Site Suresnes
France Pfizer Investigational Site Talence
France Pfizer Investigational Site Thiers
France Pfizer Investigational Site Toulon
France Pfizer Investigational Site Toulouse
France Pfizer Investigational Site Toulouse
France Pfizer Investigational Site Tourcoing
France Pfizer Investigational Site Tournefeuille
France Pfizer Investigational Site Tours
France Pfizer Investigational Site Trelissac
France Pfizer Investigational Site Tremblay en France
France Pfizer Investigational Site Triel Sur Seine
France Pfizer Investigational Site Troyes
France Pfizer Investigational Site Valenciennes
France Pfizer Investigational Site Vannes
France Pfizer Investigational Site Vauvert
France Pfizer Investigational Site Veauche
France Pfizer Investigational Site Velaux
France Pfizer Investigational Site Vendargues
France Pfizer Investigational Site Venissieux Cedex
France Pfizer Investigational Site Viarmes
France Pfizer Investigational Site Vienne
France Pfizer Investigational Site Villeneuve D'Ascq
France Pfizer Investigational Site Villeneuve la Garenne
France Pfizer Investigational Site Villeneuve Saint Georges
France Pfizer Investigational Site Villeparisis
France Pfizer Investigational Site Villepinte
France Pfizer Investigational Site Villiers Le Bel
France Pfizer Investigational Site Vizille
France Pfizer Investigational Site Voiron
France Pfizer Investigational Site Wattrelos

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP 3 months
Secondary Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP 3 months
Secondary 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% 3 months
Secondary Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP 1 month
Secondary 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% 1 month
Secondary 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 3 months
Secondary 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 1 month
Secondary Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam 3 months
See also
  Status Clinical Trial Phase
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Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A
Completed NCT01410188 - Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension Phase 1/Phase 2

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