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Real World Data Study Assessing The Persistency Of Xalacom And The Other Fixed Dose Combination Products, Duotrav And Ganfort, In The United Kingdom

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206361
First Posted: September 21, 2010
Last Update Posted: June 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention
Glaucoma Ocular Hypertension Drug: XALACOM Drug: Duotrav Drug: Ganfort

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Persistence Of Use Of Topical Prostaglandin Fixed Dose Combination In The United Kingdom Primary Care: An Observational Study In Thin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Frequency distribution of persistent and non-persistent patients across study cohorts [ Time Frame: 12 months ]
  • Frequency distribution of switchers, re-starters and discontinuing patients as well as patients commencing add-on therapy across the study cohorts [ Time Frame: 12 months ]
  • Time to discontinuation of each cohort [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension [ Time Frame: 12 months ]
  • Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy [ Time Frame: 12 months ]
  • Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists [ Time Frame: 12 months ]
  • Prostaglandin mono-therapies [ Time Frame: 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 [ Time Frame: 12 months ]
  • presented who had had (i) a 12 month history of any of the diseases or (ii) had had a history of any of the diseases. [ Time Frame: 12 months ]

Enrollment: 2015
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fixed dose prostaglandin combination Drug: XALACOM
Xalacom eye drops
Drug: Duotrav
Duotrav eye drops
Drug: Ganfort
Ganfort eye drops

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206361


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01206361     History of Changes
Other Study ID Numbers: A6111145
First Submitted: August 26, 2010
First Posted: September 21, 2010
Last Update Posted: June 29, 2011
Last Verified: June 2011

Keywords provided by Pfizer:
Real world
observational
retrospective
database analysis

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases