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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT01206361

Collaborator

(none)

2,015

Enrollment

5.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Hypertension	Drug: XALACOM Drug: Duotrav Drug: Ganfort

Study Design

Study Type:

Observational

Actual Enrollment :

2015 participants

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

fixed dose prostaglandin combination

Drug: XALACOM

Xalacom eye drops

Drug: Duotrav

Duotrav eye drops

Drug: Ganfort

Ganfort eye drops

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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