Open Angle GlaucomaNCT00121147
Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
A study testing Travatan, Azopt and Alphagan P in people with Open Angle Glaucoma and Ocular Hypertension, run by Hermann Eye Center at 21 sites in United States.
Trial summary
The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension, Pseudoexfoliation Syndrome
- What is being tested?
- Travatan, Azopt and Alphagan P
- How many people
- 200 participants
- Where
- 21 sitesUnited States
- Study dates
- Sep 2003to Oct 2005
- Phase
- Interventional
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age: 35 years
- Uni or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome (POAG is defined as having VF and optic nerve changes consistent with glaucomatous disease)
- Insufficient response to monotherapy: defined as IOP > 18mm Hg (mean diurnal) and less than 32 mm Hg on Travatan at baseline
- Informed consent and HIPPA consent obtained at screening visit prior to any study events
- Ability to adhere to study treatment visit plan
Who cannot join
- Closed, occluded, or potentially occludable angle
- History of angle closure
- Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty
- Argon laser trabeculoplasty or phacoemulsification within the last 3 months
- Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry
- Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis)
Show all 15Show fewer
- History of uveitis or previous intraocular inflammation (other than post-operatively)
- Hypersensitivity to sulfa, alpha agonists or benzalkonium chloride
- History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular)
- Use of systemic medications known to effect IOP (e.g. Alpha agonists, Beta blockers, Ace inhibitors and angiotensin II receptor blockers) which have not been stable for three months prior to baseline and the dosage is not expected to change during the course of the study
- Women
- Pregnancy (study medications have been determined to cause possible harm to the fetus)
- Women of childbearing potential who are not using contraceptive methods. Childbearing potential is defined as any woman who is not postmenopausal (12 months without a menstrual period) or surgically sterile. Contraceptive methods are defined as abstinence, having a vasectomized partner, or ongoing use of approved oral, injectable, topical or implanted contraceptives, a barrier method or an IUD
- General:
- Use of any investigational medication within one month prior to baseline visit
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Emory Healthcare Eye Center
Atlanta, Georgia, 30322
Omni Eye Services
Atlanta, Georgia, 30342
Eyecare Ophthalmology PC
Bethpage, New York, 11714
Glaucoma Consultation Service
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, 60612
Glaucoma Associates of Texas
Dallas, Texas, 75231
Kresge Eye Institute
Detroit, Michigan, 48201
University of Florida
Gainesville, Florida, 32610
The Eye Center
Hamden, Connecticut, 06518
Baylor College of Medicine
Houston, Texas, 77030
Hermann Eye Center
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Doheny Eye Institute
Los Angeles, California, 90033-4666
West Virginia University Eye Institute
Morgantown, West Virginia, 26506
Mount Sinai School of Medicine
New York, New York, 10029
Mississippi Eye Associates
Ocean Springs, Mississippi, 39564
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
The Keystone Eye Associates
Philadelphia, Pennsylvania, 19114
Lone Star Eye Associates
Sugarland, Texas, 77479
About this study
Official title: A Comparison of the Additivity of Brinzolamide Ophthalmic Suspension, 1% (Azopt) and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan P) to Travoprost Ophthalmic Solution, 0.004% (Travatan) in Patients With Elevated IOP on Travoprost. A Three Month Double-Masked, Multi-Center Trial in the United States
The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
Read the detailed description
The purpose of this research study is to compare the effect on the pressure inside the eye when Brinzolamide Ophthalmic Suspension, 1% (Azopt), a carbonic anhydrase inhibitor, and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), an alpha 2 agonist, are added to Travoprost Ophthalmic Solution, 0.004% (Travatan), a prostaglandin, in patients with primary open angle glaucoma, ocular hypertension and pseudoexfoliation syndrome. Brinzolamide Ophthalmic Suspension, 1% (Azopt), Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), and Travoprost Ophthalmic Solution, 0.004% (Travatan) are all currently approved by the FDA and on the market, being used by patients. Even though all three medications are currently approved for the purpose of the study they will be considered study medicines.
Glaucoma, Ocular Hypertension and Pseudoexfoliation syndrome have been treated with IOP-lowering medications or surgery to lower the pressure inside the eye to reduce the risk of visual field loss. Today, common treatments for a patient often begins with the prescription of a prostaglandin (Travoprost). If the prostaglandin does not lower the pressure inside the eye enough, a second drug is usually added. Topical carbonic anhydrase inhibitors (Brinzolamide) and alpha 2 agonists (Brimonidine) are common choices as additive medicines.
- Being tested
- Travatan, Azopt, Alphagan P
- Keywords
- glaucoma, pseudoexfoliation
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Exfoliation Syndrome, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TravatanDrug
AzoptDrug
Alphagan PDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
Secondary outcomes (4)
Change in IOP from baseline at each time point
IOP at 8AM (prior to dosing), 12 noon and 4 pm at month 3
Percent IOP lowering from pretreatment baseline to the three month visit. Both diurnal average and at each time point
Percent of patients reaching specific target pressures after three months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startSep 2003
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Hermann Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Robert M Feldman, M.D., Study chair, Hermann Eye Fund / University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121147
- Sponsor's protocol ID
- HEF-042
- Status last verified
- Jul 2005
- First submitted
- 13 Jul 2005
- Last updated
- 24 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Additivity of Brinzolamide Ophthalmic Suspension, 1% (Azopt) and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan P) to Travoprost Ophthalmic Solution, 0.004% (Travatan) in Patients With Elevated IOP on Travoprost. A Three Month Double-Masked, Multi-Center Trial in the United States
- ClinicalTrials.gov ID
- NCT00121147
- Acronym / sponsor ID
- HEF-042
- Keywords
- glaucoma, pseudoexfoliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Hermann Eye CenterUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Sep 2003
- Study completion
- Oct 2005
- First posted
- 21 Jul 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 purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
Detailed description
The purpose of this research study is to compare the effect on the pressure inside the eye when Brinzolamide Ophthalmic Suspension, 1% (Azopt), a carbonic anhydrase inhibitor, and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), an alpha 2 agonist, are added to Travoprost Ophthalmic Solution, 0.004% (Travatan), a prostaglandin, in patients with primary open angle glaucoma, ocular hypertension and pseudoexfoliation syndrome. Brinzolamide Ophthalmic Suspension, 1% (Azopt), Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), and Travoprost Ophthalmic Solution, 0.004% (Travatan) are all currently approved by the FDA and on the market, being used by patients. Even though all three medications are currently approved for the purpose of the study they will be considered study medicines.
Glaucoma, Ocular Hypertension and Pseudoexfoliation syndrome have been treated with IOP-lowering medications or surgery to lower the pressure inside the eye to reduce the risk of visual field loss. Today, common treatments for a patient often begins with the prescription of a prostaglandin (Travoprost). If the prostaglandin does not lower the pressure inside the eye enough, a second drug is usually added. Topical carbonic anhydrase inhibitors (Brinzolamide) and alpha 2 agonists (Brimonidine) are common choices as additive medicines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum age: 35 years
- Uni or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome (POAG is defined as having VF and optic nerve changes consistent with glaucomatous disease)
- Insufficient response to monotherapy: defined as IOP > 18mm Hg (mean diurnal) and less than 32 mm Hg on Travatan at baseline
- Informed consent and HIPPA consent obtained at screening visit prior to any study events
- Ability to adhere to study treatment visit plan
Key exclusion criteria (15 listed)
- Closed, occluded, or potentially occludable angle
- History of angle closure
- Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty
- Argon laser trabeculoplasty or phacoemulsification within the last 3 months
- Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry
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 |
|---|---|---|
| Travatan | Drug | – |
| Azopt | Drug | – |
| Alphagan P | Drug | – |
Primary outcome
Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
4 secondary outcomes
Change in IOP from baseline at each time point
IOP at 8AM (prior to dosing), 12 noon and 4 pm at month 3
Percent IOP lowering from pretreatment baseline to the three month visit. Both diurnal average and at each time point
Percent of patients reaching specific target pressures after three months of treatment.
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 24 Feb 2006.
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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.
Robert M Feldman, M.D. study chair
Hermann Eye Fund / University of Texas
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Travatan, Azopt and Alphagan P in people with Open Angle Glaucoma and Ocular Hypertension, run by Hermann Eye Center at 21 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 5 inclusion and 15 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 24 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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.
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?
Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit. 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 24 Feb 2006.