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OpenTrials
Completed

NCT Number: NCT01206361

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xalacom

Drug

Xalacom eye drops

Duotrav

Drug

Duotrav eye drops

Ganfort

Drug

Ganfort eye drops

Primary outcomes

  1. Frequency distribution of persistent and non-persistent patients across study cohorts

    Time frame: 12 months

  2. 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

  3. Time to discontinuation of each cohort

    Time frame: 12 months

Secondary outcomes

  1. Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension

    Time frame: 12 months

  2. Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy

    Time frame: 12 months

  3. Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists

    Time frame: 12 months

  4. Prostaglandin mono-therapies

    Time frame: 12 months

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 21, 2010
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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