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

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: XALACOM; Drug: Duotrav; Drug: Ganfort

• Registration Number: NCT01206361
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Status Verified: 2011-06
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2015

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fixed dose prostaglandin combination	Ganfort	-
fixed dose prostaglandin combination	XALACOM	-
fixed dose prostaglandin combination	Duotrav	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.	12 months