Glaucoma, Open-AngleNCT00334750
Distribution of Risk Factors in Ocular Hypertension and Open-Angle Glaucoma Patients in Canada
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 21 sites in Canada.
Trial summary
This descriptive, non-interventional study will collect information on the presence of risk factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- How many people
- 410 participants
- Where
- 21 sitesCanada
- Study dates
- Nov 2007to Apr 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Canadian population
Who may be able to join
- Subjects diagnosed at study visit or within 3 months of visit with OH
- OAG (to include POAG, NTG, pigmentary and pseudoexfoliation glaucoma)
Who cannot join
- No prior treatment for OH or OAG
- No prior ocular surgery or history of ocular trauma
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Canada21 sites
Pfizer Investigational Site
Brampton, Ontario, L6V 1B4
Pfizer Investigational Site
Calgary, Alberta, T3E 7M8
Pfizer Investigational Site
Edmonton, Alberta, T5H 0X5
Pfizer Investigational Site
Edmonton, Alberta, T5H 3V9
Pfizer Investigational Site
Hamilton, Ontario, L8M 1L6
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Mississauga, Ontario, L5L 1W8
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Montreal, Quebec, H1V 1G5
Pfizer Investigational Site
Nanaimo, British Columbia, V9R 5B6
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Oakville, Ontario, L6L 5G8
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 3H3
Pfizer Investigational Site
Sherbrooke, Quebec, J1K 1EB
Pfizer Investigational Site
Sydney, Nova Scotia, B1P 1P2
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, M5M 1B2
Pfizer Investigational Site
Toronto, Ontario, M5T 2S8
Pfizer Investigational Site
Vancouver, British Columbia, V6K 1V7
Pfizer Investigational Site
Williams Lake, British Columbia, V2G 1H1
Pfizer Investigational Site
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: Distribution of Risk Factors Amongst Ocular Hypertension and Open-Angle Glaucoma Patients in Canada
This descriptive, non-interventional study will collect information on the presence of risk factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in Canada.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- There is no intervention in this study.
- Keywords
- Glaucoma, Open-Angle Ocular Hypertension Risk factors Canadian
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in this study.Other
This study is collecting information on the presence of risk factors in new diagnosed OH and OAG patients in Canada.
| Study group | Role | What they receive |
|---|---|---|
| There is no intervention in this study | This study is collecting information on the presence of risk factors in new diagnosed OH and OAG patients in Canada. Receives: Other: There is no intervention in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the presence and distribution of risk factors in subjects diagnosed with OH or OAG stratified according to geographic distribution in a Canadian population in the ophthalmologist practice.
Measured: duration of study
Secondary outcomes (1)
To describe the severity of disease at the time of diagnosis and to determine if there is a correlation between risk factors, or number of risk factors, and the severity of disease at presentation.
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startNov 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Prospective
- Enrolment
- 410 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
- NCT00334750
- Sponsor's protocol ID
- A6111125
- Status last verified
- Sep 2010
- First submitted
- 5 Jun 2006
- 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
- Distribution of Risk Factors Amongst Ocular Hypertension and Open-Angle Glaucoma Patients in Canada
- ClinicalTrials.gov ID
- NCT00334750
- Acronym / sponsor ID
- A6111125
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Glaucoma, Open-Angle Ocular Hypertension Risk factors Canadian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 8 Jun 2006 (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.
This descriptive, non-interventional study will collect information on the presence of risk factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| There is no intervention in this study | – | Other: There is no intervention in this study.This study is collecting information on the presence of risk factors in new diagnosed OH and OAG patients in Canada. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canadian population
Key inclusion criteria (2 listed)
- Subjects diagnosed at study visit or within 3 months of visit with OH
- OAG (to include POAG, NTG, pigmentary and pseudoexfoliation glaucoma)
Key exclusion criteria (2 listed)
- No prior treatment for OH or OAG
- No prior ocular surgery or history of ocular trauma
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 |
|---|---|---|
| There is no intervention in this study.This study is collecting information on the presence of risk factors in new diagnosed OH and OAG patients in Canada. | Other | There is no intervention in this study |
Primary outcome
To describe the presence and distribution of risk factors in subjects diagnosed with OH or OAG stratified according to geographic distribution in a Canadian population in the ophthalmologist practice.
Time frame: duration of study
1 secondary outcome
To describe the severity of disease at the time of diagnosis and to determine if there is a correlation between risk factors, or number of risk factors, and the severity of disease at presentation.
Time frame: duration of study
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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 21 sites in Canada.
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 2 inclusion and 2 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.
Where is the study taking place?
The record lists 21 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To describe the presence and distribution of risk factors in subjects diagnosed with OH or OAG stratified according to geographic distribution in a Canadian population in the ophthalmologist practice. (time frame: duration of study). 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.