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

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Persistence Of Use Of Topical Prostaglandin Fixed Dose Combination In The United Kingdom Primary Care: An Observational Study In Thin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
fixed dose prostaglandin combination
Drug: XALACOM
Xalacom eye drops
Drug: Duotrav
Duotrav eye drops
Drug: Ganfort
Ganfort eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency distribution of persistent and non-persistent patients across study cohorts
Time Frame: 12 months
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
12 months
Time to discontinuation of each cohort
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension
Time Frame: 12 months
12 months
Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy
Time Frame: 12 months
12 months
Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists
Time Frame: 12 months
12 months
Prostaglandin mono-therapies
Time Frame: 12 months
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
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (Estimate)

September 21, 2010

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6111145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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