Clinical trial NCT00121147: Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Ocular Hypertension
Pseudoexfoliation Syndrome
Keywords: glaucoma
pseudoexfoliation
Lead sponsor: Hermann Eye Center
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2005-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
Secondary outcomes:
measure: Change in IOP from baseline at each time point
measure: IOP at 8AM (prior to dosing), 12 noon and 4 pm at month 3
measure: Percent IOP lowering from pretreatment baseline to the three month visit. Both diurnal average and at each time point
measure: Percent of patients reaching specific target pressures after three months of treatment.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Doheny Eye Institute
state: California
city: Hamden
country: United States
facility: The Eye Center
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare Eye Center
state: Georgia
city: Atlanta
country: United States
facility: Omni Eye Services
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Eye and Ear Infirmary
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Boston
country: United States
facility: Glaucoma Consultation Service
state: Massachusetts
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Ocean Springs
country: United States
facility: Mississippi Eye Associates
state: Mississippi
city: Bethpage
country: United States
facility: Eyecare Ophthalmology PC
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Keystone Eye Associates
state: Pennsylvania
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Hermann Eye Center
state: Texas
city: Sugarland
country: United States
facility: Lone Star Eye Associates
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
Study officials:
affiliation: Hermann Eye Fund / University of Texas
name: Robert M Feldman, M.D.
role: STUDY_CHAIR
References: