Ocular HypertensionPhase 4NCT00140062
Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.
A Phase 4 study testing latanoprost 0.005% (Xalatan) in people with Ocular Hypertension and Glaucoma, Open-Angle, run by Pfizer at 27 sites in 2 countries.
Trial summary
The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Glaucoma, Open-Angle
- What is being tested?
- latanoprost 0.005% (Xalatan)
- How many people
- 329 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Feb 2002to Apr 2006
- Phase
- Phase 4
- 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
Who may be able to join
- Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
- IOP of > 21 mm Hg on current treatment
Who cannot join
- Any previous or current treatment with latanoprost or other prostaglandin analogues
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
Sweden18 sites
Pfizer Investigational Site
Jönköping, 551 85
Pfizer Investigational Site
Karlstad, 652 20
Pfizer Investigational Site
Kristianstad, 291 31
Pfizer Investigational Site
Linköping
Pfizer Investigational Site
Ludvika, 771 81
Pfizer Investigational Site
Mölndal
Pfizer Investigational Site
Nacka, 131 83
Pfizer Investigational Site
Norrköping, 601 82
Pfizer Investigational Site
Norrköping, 602 36
Pfizer Investigational Site
Nyköping
Pfizer Investigational Site
Örebro, 70361
Pfizer Investigational Site
Seinajoki, 151 72
Pfizer Investigational Site
Stockholm, 113 22
Pfizer Investigational Site
Stockholm
Pfizer Investigational Site
Sundsvall, 851 86
Pfizer Investigational Site
Täby, 183 34
Pfizer Investigational Site
Uppsala, 751 85
Pfizer Investigational Site
Uppsala
Finland9 sites
Pfizer Investigational Site
Ekenäs
Pfizer Investigational Site
Helsinki, 00100
Pfizer Investigational Site
Helsinki, 00700
Pfizer Investigational Site
Kuopio, 70100
Pfizer Investigational Site
Lahti, 15110
Pfizer Investigational Site
Rovaniemi, 96200
Pfizer Investigational Site
Seinäjoki, 60100
Pfizer Investigational Site
Tampere, 33100
Pfizer Investigational Site
Turku, 20100
About this study
Official title: A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension
The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.
- Conditions
- Ocular Hypertension, Glaucoma, Open-Angle
- Being tested
- latanoprost 0.005% (Xalatan)
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
latanoprost 0.005% (Xalatan)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.
Secondary outcomes (1)
Safety and the health care utilization in the two treatment groups over 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startFeb 2002
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 329 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140062
- Sponsor's protocol ID
- 912-OPT-0091-156
- Status last verified
- Apr 2008
- First submitted
- 29 Aug 2005
- Last updated
- 7 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00140062
- Acronym / sponsor ID
- 912-OPT-0091-156
- Conditions
- Ocular Hypertension, Glaucoma, Open-Angle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- Apr 2006
- First posted
- 31 Aug 2005 (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 primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
- IOP of > 21 mm Hg on current treatment
Key exclusion criteria (1 listed)
- Any previous or current treatment with latanoprost or other prostaglandin analogues
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 |
|---|---|---|
| latanoprost 0.005% (Xalatan) | Drug | – |
Primary outcome
Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.
1 secondary outcome
Safety and the health care utilization in the two treatment groups over 36 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 7 Apr 2008.
- 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
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing latanoprost 0.005% (Xalatan) in people with Ocular Hypertension and Glaucoma, Open-Angle, run by Pfizer at 27 sites in 2 countries.
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 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 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Sweden, Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.. 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 7 Apr 2008.