Open Angle GlaucomaPhase 3NCT00277498
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 Open Angle Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 64 sites in United States.
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
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Xalacom, Xalatan and Timolol
- How many people
- 528 participants
- Where
- 64 sitesUnited States
- Study dates
- Dec 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
64 sites in 1 country.
64 sites in 1 country
United States64 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48105
Pfizer Investigational Site
Artesia, California, 90701
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Austin, Texas, 78746
Pfizer Investigational Site
Bangor, Maine, 04401
Pfizer Investigational Site
Birmingham, Alabama, 35216
Pfizer Investigational Site
Bourbonnais, Illinois, 60914
Pfizer Investigational Site
Brooklyn, New York, 11215
Pfizer Investigational Site
Calumet City, Illinois, 60409
Pfizer Investigational Site
Charleston, South Carolina, 29403
Pfizer Investigational Site
Charleston, South Carolina, 29414
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Chicago, Illinois, 60617
Pfizer Investigational Site
Cleveland, Ohio, 44115-3176
Pfizer Investigational Site
Colorado Springs, Colorado, 80907
Pfizer Investigational Site
Creve Coeur, Missouri, 63141-6846
Pfizer Investigational Site
Dallas, Texas, 75231-5185
Pfizer Investigational Site
Detroit, Michigan, 48201-1423
Pfizer Investigational Site
Durham, North Carolina, 27704-2122
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
El Paso, Texas, 79902
Pfizer Investigational Site
El Paso, Texas, 79904
Pfizer Investigational Site
Evansville, Indiana, 47713
Pfizer Investigational Site
Flagstaff, Arizona, 86001
Pfizer Investigational Site
Fort Worth, Texas, 76102-4427
Pfizer Investigational Site
Fredericksburg, Virginia, 22405
Pfizer Investigational Site
Gainesville, Florida, 32605
Pfizer Investigational Site
Greensboro, North Carolina, 27408-7022
Pfizer Investigational Site
Houston, Texas, 77025-1635
Pfizer Investigational Site
Houston, Texas, 77055
Pfizer Investigational Site
Idaho Falls, Idaho, 83404
Pfizer Investigational Site
Iowa City, Iowa, 52245
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Lecanto, Florida, 34461
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Madison, Indiana, 47250
Pfizer Investigational Site
Maryville, Tennessee, 37803
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
New Albany, Indiana, 47150
Pfizer Investigational Site
New York, New York, 10032-3701
Pfizer Investigational Site
Newburgh, Indiana, 47630
Pfizer Investigational Site
Newport Beach, California, 92663
Pfizer Investigational Site
Panama City, Florida, 32405
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19148
Pfizer Investigational Site
Piscataway, New Jersey, 08854-4143
Pfizer Investigational Site
Princeton, New Jersey, 08540-3211
Pfizer Investigational Site
Reading, Massachusetts, 01867
Pfizer Investigational Site
Reading, Pennsylvania, 19606
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Roseburg, Oregon, 97470
Pfizer Investigational Site
Sacramento, California, 95815
Pfizer Investigational Site
San Antonio, Texas, 78205
Pfizer Investigational Site
San Antonio, Texas, 78209
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
San Francisco, California, 94105
Pfizer Investigational Site
Seattle, Washington, 98133
Pfizer Investigational Site
Stillwater, Minnesota, 55082
Pfizer Investigational Site
Warrensburg, Missouri, 64093
Pfizer Investigational Site
Washington, Missouri, 63090
Pfizer Investigational Site
Wichita, Kansas, 67208
Pfizer Investigational Site
Winston-Salem, North Carolina, 27101
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610
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 In The United States.
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
- Open Angle Glaucoma, 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 posted16 Jan 2006 (estimated)
- Study startDec 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 528 participants
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
- NCT00277498
- Sponsor's protocol ID
- A6641044
- Status last verified
- Jun 2008
- First submitted
- 13 Jan 2006
- Last updated
- 18 Feb 2021
- Results posted
- No
Publications
Higginbotham EJ, Olander KW, Kim EE, Grunden JW, Kwok KK, Tressler CS; United States Fixed-Combination Study Group. Fixed combination of latanoprost and timolol vs individual components for primary open-angle glaucoma or ocular hypertension: a randomized, double-masked study. Arch Ophthalmol. 2010 Feb;128(2):165-72. doi: 10.1001/archophthalmol.2009.384.
PubMed 20142538
Study at a glance
From the registry record, last updated by the sponsor on 18 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 In The United States.
- ClinicalTrials.gov ID
- NCT00277498
- Acronym / sponsor ID
- A6641044
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 16 Jan 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.
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 18 Feb 2021.
- Derived from this study: PubMed 20142538Higginbotham EJ, Olander KW, Kim EE, Grunden JW, Kwok KK, Tressler CS; United States Fixed-Combination Study Group. Fixed combination of latanoprost and timolol vs individual components for primary open-angle glaucoma or ocular hypertension: a randomized, double-masked study. Arch Ophthalmol. 2010 Feb;128(2):165-72. doi: 10.1001/archophthalmol.2009.384.
- 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
64 sites in 1 country: 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 Open Angle Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 64 sites in United States.
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 18 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 64 sites in United States. 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?
On the ClinicalTrials.gov record for NCT00277498, which also lists 1 linked publication.
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 18 Feb 2021.