NCT01206361

Brief Summary

The hypothesis is that there is no difference in persistency between Xalacom and the alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,015

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

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

February 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2010

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
Last Updated

February 2, 2021

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

August 26, 2010

Last Update Submit

February 1, 2021

Conditions

Keywords

Real worldobservationalretrospectivedatabase analysis

Outcome Measures

Primary Outcomes (3)

  • Frequency distribution of persistent and non-persistent patients across study cohorts

    12 months

  • Frequency distribution of switchers, re-starters and discontinuing patients as well as patients commencing add-on therapy across the study cohorts

    12 months

  • Time to discontinuation of each cohort

    12 months

Secondary Outcomes (6)

  • Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension

    12 months

  • Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy

    12 months

  • Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists

    12 months

  • Prostaglandin mono-therapies

    12 months

  • The cohort of patients which were evaluated in this study were investigated for the presence of history of disease for asthma, cardiovascular disease, diabetes, renal failure and systemic hypertension. The number of patients in each cohort were

    12 months

  • +1 more secondary outcomes

Study Arms (1)

fixed dose prostaglandin combination

Drug: XALACOMDrug: DuotravDrug: Ganfort

Interventions

Xalacom eye drops

fixed dose prostaglandin combination

Duotrav eye drops

fixed dose prostaglandin combination

Ganfort eye drops

fixed dose prostaglandin combination

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who had received a prescription for either Xalacom, Ganfort and DuoTrav, \> 18 years old, diagnosed with glaucoma or ocular hypertension, registered at the primary care practice for \> 12 months

You may qualify if:

  • Patients who had received a prescription for either Xalacom, Ganfort and DuoTrav
  • Greater than 18 years old
  • Diagnosed with glaucoma or ocular hypertension
  • Registered at the primary care practice for \> 12 months

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

XalacomDuotravGanfort

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2010

First Posted

September 21, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

February 2, 2021

Record last verified: 2011-06