Glaucoma, Open-AnglePhase 3NCT00159653
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma
A Phase 3 study testing Xalacom, Xalatan and Timolol in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 55 sites in 2 countries.
Trial summary
To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12. 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, Xalatan and Timolol
- How many people
- 500 participants
- Where
- 55 sitesin 2 countries
- Study dates
- Jul 2005to Jun 2007
- 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
- Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening
Who cannot join
- Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
- History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
Trial locations and contacts
55 sites in 2 countries.
55 sites in 2 countries
United States38 sites
Pfizer Investigational Site
Amarillo, Texas, 79106
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Atlanta, Georgia, 30349
Pfizer Investigational Site
Bethpage, New York, 11714-5701
Pfizer Investigational Site
Cape Coral, Florida, 33904
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Charlotte, North Carolina, 28262
Pfizer Investigational Site
Cranberry Township, Pennsylvania, 16066
Pfizer Investigational Site
Danbury, Connecticut, 06810-4004
Pfizer Investigational Site
High Point, North Carolina, 27262
Pfizer Investigational Site
Homewood, Illinois, 60430
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Lakeland, Florida, 33805-2440
Pfizer Investigational Site
Lincoln, Nebraska, 68506
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Matthews, North Carolina, 28105
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Morrow, Georgia, 30260
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464-3060
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
New York, New York, 10029-6574
Pfizer Investigational Site
Newark, New Jersey, 07103-2499
Pfizer Investigational Site
North Charleston, South Carolina, 29406
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Omaha, Nebraska, 68198-5540
Pfizer Investigational Site
Ormond Beach, Florida, 32174
Pfizer Investigational Site
Overland Park, Kansas, 66213
Pfizer Investigational Site
Phoenix, Arizona, 85032
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15238-3103
Pfizer Investigational Site
Poway, California, 92064
Pfizer Investigational Site
Redding, California, 96002-2122
Pfizer Investigational Site
Redding, California, 96002
Pfizer Investigational Site
Saint Joseph, Michigan, 49085
Pfizer Investigational Site
Shreveport, Louisiana, 71104
Pfizer Investigational Site
Tampa, Florida, 33603
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
Wilmington, North Carolina, 28403
Canada17 sites
Pfizer Investigational Site
Barrie, Ontario, L4M 4S5
Pfizer Investigational Site
Bridgewater, Nova Scotia, B4V 3N2
Pfizer Investigational Site
Calgary, Alberta, T2T 5R6
Pfizer Investigational Site
Markham, Ontario, L6B 1A1
Pfizer Investigational Site
Mississauga, Ontario, L5A 4E4
Pfizer Investigational Site
Moncton, New Brunswick, E1C 2N7
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
Saint John, New Brunswick, E2L 1G3
Pfizer Investigational Site
Saint John, New Brunswick, E2L 4W3
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 0M7
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 3H3
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, M5B 1W8
Pfizer Investigational Site
Toronto, Ontario, M6H 2H1
About this study
Official title: A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension.
To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Xalacom, Xalatan, Timolol
- 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
XalatanDrug
TimololDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean IOP measurements obtained in the study eye at each time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2007
- Study completionJun 2007
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 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
- NCT00159653
- Sponsor's protocol ID
- A6641027
- Status last verified
- Oct 2012
- First submitted
- 8 Sep 2005
- Last updated
- 21 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension.
- ClinicalTrials.gov ID
- NCT00159653
- Acronym / sponsor ID
- A6641027
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 12 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 demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening
Key exclusion criteria (2 listed)
- Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
- History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
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 | – |
| Xalatan | Drug | – |
| Timolol | Drug | – |
Primary outcome
The mean IOP measurements obtained in the study eye at each time point
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 21 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
55 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xalacom, Xalatan and Timolol in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 55 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 1 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 21 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 55 sites in United States, 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.
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?
The mean IOP measurements obtained in the study eye at each time point. 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 21 Feb 2021; AzTrials last refreshed its copy on 29 Oct 2026.