Glaucoma, Open-AnglePhase 3NCT00150267
A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
A Phase 3 study testing Xalacom in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Pfizer at 74 sites in 12 countries.
Trial summary
To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Xalacom
- How many people
- 976 participants
- Where
- 74 sitesin 12 countries
- Study dates
- Feb 2002to not given
- Phase
- Phase 3
- 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
- Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers
Who cannot join
- Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.
Trial locations and contacts
74 sites in 12 countries.
74 sites in 12 countries
Spain13 sites
Pfizer Investigational Site
Almería, Almeria, 04009
Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Barcelona, Barcelona, 08025
Pfizer Investigational Site
Bilbao, Vizcaya, 48903
Pfizer Investigational Site
Getafe, Madrid, 28905
Pfizer Investigational Site
Lugo, Lugo, 27004
Pfizer Investigational Site
Madrid, Madrid, 28034
Pfizer Investigational Site
Málaga, Malaga, 29009
Pfizer Investigational Site
Palma de Mallorca, Balearic Islands, 07500
Pfizer Investigational Site
Terrassa, Barcelona, 08221
Pfizer Investigational Site
Valencia, Valencia, 46014
Pfizer Investigational Site
Valladolid, Valladolid, 47005
Pfizer Investigational Site
Zaragoza, Zaragoza, 50009
France10 sites
Pfizer Investigational Site
Aire Sur Adour, 40800
Pfizer Investigational Site
Carcassonne, 11000
Pfizer Investigational Site
Dijon, 21000
Pfizer Investigational Site
Figeac, 46100
Pfizer Investigational Site
Haguenau, 67500
Pfizer Investigational Site
Le Cannet, 06110
Pfizer Investigational Site
Loos, 59120
Pfizer Investigational Site
Marseille, 13012
Pfizer Investigational Site
Paris, 75011
Pfizer Investigational Site
Versailles, 78000
United Kingdom10 sites
Pfizer Investigational Site
Birmingham, B9 5SS
Pfizer Investigational Site
Bolton, Lancs
Pfizer Investigational Site
Bristol, Gloucestershire, BS1 2LX
Pfizer Investigational Site
Cheltenham, Gloucestershire, GL53 7AN
Pfizer Investigational Site
Glasgow, G4 0SF
Pfizer Investigational Site
Lancaster, LA1 4RP
Pfizer Investigational Site
London
Pfizer Investigational Site
Norwich, Norfolk, NR4 7UZ
Pfizer Investigational Site
Redhill, Surrey, RH1 5RH
Pfizer Investigational Site
Uxbridge, Middlesex, UB8 3NN
Germany8 sites
Pfizer Investigational Site
Erlangen, 91052
Pfizer Investigational Site
Freising, 85354
Pfizer Investigational Site
Gerolzhofen, 97447
Pfizer Investigational Site
Hirschaid, 96114
Pfizer Investigational Site
Hösbach, 63768
Pfizer Investigational Site
Mainz, 55116
Pfizer Investigational Site
Mainz, 55124
Pfizer Investigational Site
Würzburg, 97070
Italy8 sites
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Florence, 50139
Pfizer Investigational Site
Milan, 20142
Pfizer Investigational Site
Padova, 35100
Pfizer Investigational Site
Perugia, 06122
Pfizer Investigational Site
Pisa, 56127
Pfizer Investigational Site
Siena, Siena, 23100
Pfizer Investigational Site
Torino
Belgium6 sites
Pfizer Investigational Site
Antwerp, 2020
Pfizer Investigational Site
Brussels, 1090
Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Liège, B-4000
Greece5 sites
Pfizer Investigational Site
Athens, 10 672
Pfizer Investigational Site
Kavala
Pfizer Investigational Site
Pátrai
Pfizer Investigational Site
Piraeus, Nikea-Piraeus, 184 54
Pfizer Investigational Site
Thessaloniki
Sweden5 sites
Pfizer Investigational Site
Motala
Pfizer Investigational Site
Örebro, 701 85
Pfizer Investigational Site
Stockholm
Pfizer Investigational Site
Uppsala, 751 85
Pfizer Investigational Site
Västerås, 721 89
Netherlands3 sites
Pfizer Investigational Site
Alkmaar, 1815 JD
Pfizer Investigational Site
Gouda, 2805 AH
Pfizer Investigational Site
Rijswijk, 2289 CA
Australia2 sites
Pfizer Investigational Site
Sydney, New South Wales, 2000
Pfizer Investigational Site
Sydney, New South Wales, 2067
Denmark2 sites
Pfizer Investigational Site
København Ø, 2100
Pfizer Investigational Site
Odense C, 5000
Ireland2 sites
Pfizer Investigational Site
Ennis, Co. Clare
Pfizer Investigational Site
Galway
About this study
To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Xalacom
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XalacomDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of increase of iris pigmentation
incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
occurrence of ocular/periorbital adverse events
occurrence of serious adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startFeb 2002
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 976 participants (actual)
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
- NCT00150267
- Sponsor's protocol ID
- 912-OPT-0076-019
- Status last verified
- Nov 2008
- First submitted
- 6 Sep 2005
- Last updated
- 5 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00150267
- Acronym / sponsor ID
- 912-OPT-0076-019
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 976 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- First posted
- 8 Sep 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.
To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (1 listed)
- Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers
Key exclusion criteria (1 listed)
- Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.
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 |
|---|---|---|
| Xalacom | Drug | – |
Primary outcome
Incidence of increase of iris pigmentation
incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
occurrence of ocular/periorbital adverse events
occurrence of serious adverse events.
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 5 Nov 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Glaucoma, Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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
74 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xalacom in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Pfizer at 74 sites in 12 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 1 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 5 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in Spain, France, United Kingdom, Germany, Italy and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of increase of iris pigmentation. The study lists 4 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 5 Nov 2008.