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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01206361
First received: August 26, 2010
Last updated: June 28, 2011
Last verified: June 2011
  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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to discontinuation of each cohort [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Prostaglandin mono-therapies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206361

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01206361     History of Changes
Other Study ID Numbers: A6111145
Study First Received: August 26, 2010
Last Updated: June 28, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pfizer:
Real world
observational
retrospective
database analysis

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014