NCT00801437

Brief Summary

This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
457

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
1 country

39 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

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 18, 2021

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

November 19, 2008

Last Update Submit

February 17, 2021

Conditions

Keywords

glaucoma, open-angle, non-interventional study, safety, tolerability

Outcome Measures

Primary Outcomes (2)

  • Incidence of ocular hyperemia

    12 months

  • safety of treatment

    12 months

Secondary Outcomes (1)

  • effectiveness in IOP lowering

    12 months

Study Arms (1)

Xalacom treatment

patients with primary glaucoma

Drug: Xalacom

Interventions

Xalacom 1 drop into the affected eye daily

Xalacom treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \>18 years with primary open angle glaucoma or ocular hypertension

You may qualify if:

  • primary open angle glaucoma
  • ocular hypertension
  • age \>18 years

You may not qualify if:

  • bradycardia
  • obstructive pulmonary disease
  • hypersensitivity to the drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Pfizer Investigational Site

Banovce N. Bebravou, 957 01, Slovakia

Location

Pfizer Investigational Site

Banská Bystrica, 975 17, Slovakia

Location

Pfizer Investigational Site

Bojnice, 972 01, Slovakia

Location

Pfizer Investigational Site

Bratislava, 811 05, Slovakia

Location

Pfizer Investigational Site

Bratislava, 820 07, Slovakia

Location

Pfizer Investigational Site

Bratislava, 833 01, Slovakia

Location

Pfizer Investigational Site

Bratislava, 851 04, Slovakia

Location

Pfizer Investigational Site

Brezno, 977 01, Slovakia

Location

Pfizer Investigational Site

Dunajská Streda, Slovakia

Location

Pfizer Investigational Site

Galanta, Slovakia

Location

Pfizer Investigational Site

Kežmarok, 060 01, Slovakia

Location

Pfizer Investigational Site

Košice, 040 01, Slovakia

Location

Pfizer Investigational Site

Košice, 04004, Slovakia

Location

Pfizer Investigational Site

Krompachy, 053 42, Slovakia

Location

Pfizer Investigational Site

Lipany, 080 01, Slovakia

Location

Pfizer Investigational Site

Lučenec, 984 01, Slovakia

Location

Pfizer Investigational Site

Martin, 036 01, Slovakia

Location

Pfizer Investigational Site

Myjava, 907 13, Slovakia

Location

Pfizer Investigational Site

Nitra, Slovakia

Location

Pfizer Investigational Site

Nová Baňa, 968 01, Slovakia

Location

Pfizer Investigational Site

Nove Mesto N. Vahom, 915 01, Slovakia

Location

Pfizer Investigational Site

Nové Zámky, Slovakia

Location

Pfizer Investigational Site

Poprad, 058 01, Slovakia

Location

Pfizer Investigational Site

Prešov, 080 01, Slovakia

Location

Pfizer Investigational Site

Rimavská Sobota, 979 01, Slovakia

Location

Pfizer Investigational Site

Rožňava, 048 01, Slovakia

Location

Pfizer Investigational Site

Ružomberok, 034 01, Slovakia

Location

Pfizer Investigational Site

Sabinov, 083 01, Slovakia

Location

Pfizer Investigational Site

Sliač, 962 31, Slovakia

Location

Pfizer Investigational Site

Snina, 06901, Slovakia

Location

Pfizer Investigational Site

Spišská Nová Ves, 052 01, Slovakia

Location

Pfizer Investigational Site

Stará Ľubovňa, 064 01, Slovakia

Location

Pfizer Investigational Site

Stará Turá, 916 01, Slovakia

Location

Pfizer Investigational Site

Šaľa, Slovakia

Location

Pfizer Investigational Site

Topoľčany, 955 01, Slovakia

Location

Pfizer Investigational Site

Zlaté Moravce, Slovakia

Location

Pfizer Investigational Site

Zvolen, 960 01, Slovakia

Location

Pfizer Investigational Site

Žiar nad Hronom, 965 01, Slovakia

Location

Pfizer Investigational Site

Žilina, 010 01, Slovakia

Location

Related Links

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Interventions

Xalacom

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2008

First Posted

December 3, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 18, 2021

Record last verified: 2011-06

Locations