GlaucomaPhase 4XLTNCT00847483
Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-weeks, Masked Evaluator, Phase IV Multi-center Study in the US
A Phase 4 study testing latanoprost 0.005% ophthalmic solution, Travoprost 004% sterile ophthalmic solution and Bimatoprost .03% sterile ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 40 sites in United States.
Trial summary
Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- latanoprost 0.005% ophthalmic solution, Travoprost 004% sterile ophthalmic solution and Bimatoprost .03% sterile ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 40 sitesUnited States
- Study dates
- Jan 2002to Aug 2002
- 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 primary open angle glaucoma (POAG), exfoliative glaucoma, pigmentary glaucoma or ocular hypertension (glaucoma is defined as either visual fields defect or glaucomatous changes of the optic nerve head in association with elevated intraocular pressure. Ocular hypertension is defined as IOP ≥ 21 mmHg at diagnosis).
- Is currently receiving (at the screen visit) or has received topical monotherapy or dual therapy (within the past 6 months) for POAG or ocular hypertension.
- Required washout periods are 4 weeks for -adrenergic antagonists, prostaglandin analogues (including latanoprost, unoprostone, travoprost and bimatoprost) and 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors, prior to the baseline visit.
- Mean 8 AM IOP ≥ 23 mmHg at the baseline visit for all patients. Patients should be assigned treatment only after the 8 PM IOP is obtained.
- Visual acuity (best corrected) equal to or better than 20/200 (Snellen). ETDRS charts may be used and converted to Snellen units.
- Informed Consent: Signed Informed Consent is obtained at the screen visit.
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- Able to adhere to treatment/visit planUnilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
- Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
- IOP of 22mmHg or higher obtained during the pre-study period.
Who cannot join
- Ocular conditions
- Closed/barely open anterior chamber angle or history of acute angle closure. (Patients who are diagnosed with POAG after a successful peripheral iridotomy may be enrolled).
- History of ALT (Argon Laser Trabeculoplasty) within 3 months prior to the screen visit (the unlasered eye may be enrolled as the study eye).
- History of any ocular filtering surgical intervention (the unfiltered eye may be enrolled as the study eye).
- Ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to screen visit. (Applies to both fellow and study eyes.)
- Hypersensitivity to benzalkonium chloride or to any other component in latanoprost (Xalatan), travoprost (Travatan) or bimatoprost (Lumigan).
Show all 14Show fewer
- Other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.
- Other conditions
- Use of systemic medication known to affect IOP (i.e., alpha-adrenergic agonists, beta-adrenergic antagonists, calcium channel blockers, ACE inhibitors and/or angiotensin II receptor blockers, or corticosteroids), unless the patient and the medication dosage have been stable for three months prior to the screen visit and the dosage is not expected to change during the study.
- Women
- Women of childbearing potential (WOCBP) who are not using contraceptive methods. Women of childbearing potential are defined as women who are not surgically sterile or not postmenopausal (at least 12 months without a menstrual period). Contraception is defined as abstinence, having a vasectomized partner, or the ongoing use of approved oral, injectable or implanted contraceptives, a barrier method, or an IUD.
- Pregnancy. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the screen visit and baseline visit.
- Nursing mothers General
- Use of any investigational medication within 30 days prior to screen visit.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Pfizer Investigational Site
Atlanta, Georgia, 30339
Pfizer Investigational Site
Bangor, Maine, 04401
Pfizer Investigational Site
Bellflower, California, 90706
Pfizer Investigational Site
Bloomfield, New Jersey, 07003
Pfizer Investigational Site
Bloomingdale, Illinois, 60108
Pfizer Investigational Site
Charleston, South Carolina, 29412
Pfizer Investigational Site
Charleston, South Carolina, 29414
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
El Paso, Texas, 79902
Pfizer Investigational Site
Evansville, Indiana, 47710
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Houston, Texas, 77025
Pfizer Investigational Site
Inglewood, California, 90301
Pfizer Investigational Site
Kansas City, Missouri, 64111
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Lakeland, Florida, 33805
Pfizer Investigational Site
Las Vegas, Nevada, 89104
Pfizer Investigational Site
Layton, Utah, 84041
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Maryville, Tennessee, 37803
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Norfolk, Virginia, 23505
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Omaha, Nebraska, 68198-5540
Pfizer Investigational Site
Ormond Beach, Florida, 32174
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15224
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92116
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
Shreveport, Louisiana, 771104
Pfizer Investigational Site
Streetsboro, Ohio, 44241
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
Virginia Beach, Virginia, 23456
Pfizer Investigational Site
Wenatchee, Washington, 98801
Pfizer Investigational Site
Willingboro, New Jersey, 08046
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Comparison of Latanoprost (Xalatan) With Travoprost (Travatan) and Bimatoprost (Lumigan) in Patients With Elevated Intraocular Pressure. A Twelve-week, Masked Evaluator, Phase IV, Multicenter Study in the United States. (Xalatan vs Travatan vs Lumigan).
Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- latanoprost 0.005% ophthalmic solution, Travoprost 004% sterile ophthalmic solution, Bimatoprost .03% sterile ophthalmic solution
- Keywords
- glaucoma, ocular hypertension, latanoprost, travoprost, bimatoprost
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
latanoprost 0.005% ophthalmic solutionDrug
Also called Xalatan
One drop in the evening in the affected eye(s) at 8:00pm
Travoprost 004% sterile ophthalmic solutionDrug
Also called Travatan
One drop in the evening in the affected eye(s) at 8:00pm
Bimatoprost .03% sterile ophthalmic solutionDrug
Also called Lumigan
One drop in the evening in the affected eye(s) at 8:00pm
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost | Active comparator | Not described Receives: Drug: latanoprost 0.005% ophthalmic solution |
| Travoprost | Active comparator | Not described Receives: Drug: Travoprost 004% sterile ophthalmic solution |
| Bimatoprost | Active comparator | Not described Receives: Drug: Bimatoprost .03% sterile ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period.
Measured: 12 weeks
The mean change since baseline of Week 12 IOP measured at the time of peak (8:00AM) drug effect.
Measured: 12 weeks
Secondary outcomes (3)
To study the safety variables within and between all treatment groups over 12 weeks
Measured: 12 weeks
The mean change since baseline of Week 12 IOP measured at the time of trough (8:00PM) drug effect. The mean percentage change since baseline of diurnal IOP at Week 12.
Measured: 12 weeks
The mean change since baseline of Week 12 IOP measured at the times of peak (8:00AM) and trough (8:00PM) drug effects evaluated by race. The percentage of patient withdrawals from the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJan 2002
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 375 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
- NCT00847483
- Sponsor's protocol ID
- XALA-0091-157
- Other IDs
- A6111081
- Acronym
- XLT
- Status last verified
- Feb 2009
- First submitted
- 16 Feb 2009
- 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
- A Comparison of Latanoprost (Xalatan) With Travoprost (Travatan) and Bimatoprost (Lumigan) in Patients With Elevated Intraocular Pressure. A Twelve-week, Masked Evaluator, Phase IV, Multicenter Study in the United States. (Xalatan vs Travatan vs Lumigan).
- ClinicalTrials.gov ID
- NCT00847483
- Acronym / sponsor ID
- XLT / XALA-0091-157
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, ocular hypertension, latanoprost, travoprost, bimatoprost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 19 Feb 2009 (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.
Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Latanoprost | Active comparator | Drug: latanoprost 0.005% ophthalmic solution |
| Travoprost | Active comparator | Drug: Travoprost 004% sterile ophthalmic solution |
| Bimatoprost | Active comparator | Drug: Bimatoprost .03% sterile ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Unilateral or bilateral primary open angle glaucoma (POAG), exfoliative glaucoma, pigmentary glaucoma or ocular hypertension (glaucoma is defined as either visual fields defect or glaucomatous changes of the optic nerve head in association with elevated intraocular pressure. Ocular hypertension is defined as IOP ≥ 21 mmHg at diagnosis).
- Is currently receiving (at the screen visit) or has received topical monotherapy or dual therapy (within the past 6 months) for POAG or ocular hypertension.
- Required washout periods are 4 weeks for -adrenergic antagonists, prostaglandin analogues (including latanoprost, unoprostone, travoprost and bimatoprost) and 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors, prior to the baseline visit.
- Mean 8 AM IOP ≥ 23 mmHg at the baseline visit for all patients. Patients should be assigned treatment only after the 8 PM IOP is obtained.
- Visual acuity (best corrected) equal to or better than 20/200 (Snellen). ETDRS charts may be used and converted to Snellen units.
Key exclusion criteria (14 listed)
- Ocular conditions
- Closed/barely open anterior chamber angle or history of acute angle closure. (Patients who are diagnosed with POAG after a successful peripheral iridotomy may be enrolled).
- History of ALT (Argon Laser Trabeculoplasty) within 3 months prior to the screen visit (the unlasered eye may be enrolled as the study eye).
- History of any ocular filtering surgical intervention (the unfiltered eye may be enrolled as the study eye).
- Ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to screen visit. (Applies to both fellow and study eyes.)
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% ophthalmic solutionAlso: XalatanOne drop in the evening in the affected eye(s) at 8:00pm | Drug | Latanoprost |
| Travoprost 004% sterile ophthalmic solutionAlso: TravatanOne drop in the evening in the affected eye(s) at 8:00pm | Drug | Travoprost |
| Bimatoprost .03% sterile ophthalmic solutionAlso: LumiganOne drop in the evening in the affected eye(s) at 8:00pm | Drug | Bimatoprost |
Primary outcome
To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period.
Time frame: 12 weeks
The mean change since baseline of Week 12 IOP measured at the time of peak (8:00AM) drug effect.
Time frame: 12 weeks
3 secondary outcomes
To study the safety variables within and between all treatment groups over 12 weeks
Time frame: 12 weeks
The mean change since baseline of Week 12 IOP measured at the time of trough (8:00PM) drug effect. The mean percentage change since baseline of diurnal IOP at Week 12.
Time frame: 12 weeks
The mean change since baseline of Week 12 IOP measured at the times of peak (8:00AM) and trough (8:00PM) drug effects evaluated by race. The percentage of patient withdrawals from the study
Time frame: 12 weeks
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
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing latanoprost 0.005% ophthalmic solution, Travoprost 004% sterile ophthalmic solution and Bimatoprost .03% sterile ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 40 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 9 inclusion and 14 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 40 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 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?
To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period. (time frame: 12 weeks). The study lists 2 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 2 Feb 2021.