GlaucomaNCT01206361
Real World Data Study Assessing The Persistency Of Xalacom And The Other Fixed Dose Combination Products, Duotrav And Ganfort, In The United Kingdom
An observational study of Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- XALACOM, Duotrav and Ganfort
- How many people
- 2,015 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: 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.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- XALACOM, Duotrav, Ganfort
- Keywords
- Real world, observational, retrospective, database analysis
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XALACOMDrug
Xalacom eye drops
DuotravDrug
Duotrav eye drops
GanfortDrug
Ganfort eye drops
| Study group | Role | What they receive |
|---|---|---|
| fixed dose prostaglandin combination | Not described Receives: Drug: XALACOM; Drug: Duotrav; Drug: Ganfort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency distribution of persistent and non-persistent patients across study cohorts
Measured: 12 months
Frequency distribution of switchers, re-starters and discontinuing patients as well as patients commencing add-on therapy across the study cohorts
Measured: 12 months
Time to discontinuation of each cohort
Measured: 12 months
Secondary outcomes (6)
Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension
Measured: 12 months
Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy
Measured: 12 months
Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists
Measured: 12 months
Prostaglandin mono-therapies
Measured: 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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206361
- Sponsor's protocol ID
- A6111145
- Status last verified
- Jun 2011
- First submitted
- 26 Aug 2010
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence Of Use Of Topical Prostaglandin Fixed Dose Combination In The United Kingdom Primary Care: An Observational Study In Thin
- ClinicalTrials.gov ID
- NCT01206361
- Acronym / sponsor ID
- A6111145
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Real world, observational, retrospective, database analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,015 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fixed dose prostaglandin combination | – | Drug: XALACOM, Drug: Duotrav, Drug: Ganfort |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XALACOMXalacom eye drops | Drug | fixed dose prostaglandin combination |
| DuotravDuotrav eye drops | Drug | fixed dose prostaglandin combination |
| GanfortGanfort eye drops | Drug | fixed dose prostaglandin combination |
Primary outcome
Frequency distribution of persistent and non-persistent patients across study cohorts
Time frame: 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
Time to discontinuation of each cohort
Time frame: 12 months
6 secondary outcomes
Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension
Time frame: 12 months
Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy
Time frame: 12 months
Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists
Time frame: 12 months
Prostaglandin mono-therapies
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency distribution of persistent and non-persistent patients across study cohorts (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.