NCT00140049

Brief Summary

To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon \& 4 PM during a 12 week treatment.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4

Geographic Reach
5 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

February 18, 2021

Status Verified

November 1, 2007

First QC Date

August 29, 2005

Last Update Submit

February 17, 2021

Conditions

Glaucoma, Open AngleOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • The mean IOP measurements obtained in the study eye at each time point

Interventions

XalacomDRUG
CosoptDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

You may not qualify if:

  • Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
  • History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Pfizer Investigational Site

Caen, 14033, France

Location

Pfizer Investigational Site

Clermont-Ferrand, 63003, France

Location

Pfizer Investigational Site

Lyon, 69437, France

Location

Pfizer Investigational Site

Marseille, 13385, France

Location

Pfizer Investigational Site

Saint-Herblain, 44800, France

Location

Pfizer Investigational Site

Darmstadt, 64283, Germany

Location

Pfizer Investigational Site

Darmstadt, 64297, Germany

Location

Pfizer Investigational Site

Landau / Pfalz, 76829, Germany

Location

Pfizer Investigational Site

Regenstauf, 93128, Germany

Location

Pfizer Investigational Site

Schorndorf, 73614, Germany

Location

Pfizer Investigational Site

Starnberg, 82319, Germany

Location

Pfizer Investigational Site

Heraklion, Crete, 71110, Greece

Location

Pfizer Investigational Site

Thessaloniki, Macedonia, 546 36, Greece

Location

Pfizer Investigational Site

Alexandroupoli, 68100, Greece

Location

Pfizer Investigational Site

Larissa, 41110, Greece

Location

Pfizer Investigational Site

Chieti, 66013, Italy

Location

Pfizer Investigational Site

Foggia, 71100, Italy

Location

Pfizer Investigational Site

Genova, 16132, Italy

Location

Pfizer Investigational Site

Milan, 20132, Italy

Location

Pfizer Investigational Site

Monza (MI), 20052, Italy

Location

Pfizer Investigational Site

Pisa, 56126, Italy

Location

Pfizer Investigational Site

örebro, 703 61, Sweden

Location

Pfizer Investigational Site

Malmo, 205 02, Sweden

Location

Pfizer Investigational Site

Mölndal, 431 80, Sweden

Location

Pfizer Investigational Site

Sundsvall, 851 86, Sweden

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Xalacomdorzolamide-timolol combination

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

July 1, 2005

Study Completion

July 1, 2006

Last Updated

February 18, 2021

Record last verified: 2007-11

Locations

GR(4)FR(5)DE(6)IT(6)SE(4)