The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.

Condition	Intervention
Open Angle Glaucoma Ocular Hypertension Pseudoexfoliation Syndrome	Drug: Travatan  Drug: Azopt  Drug: Alphagan P

Further Study Details: 

Primary Outcomes: Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
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.
Expected Total Enrollment:  200

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.

Ages Eligible for Study:  35 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

California
      Doheny Eye Institute, Los Angeles,  California,  90033-4666,  United States
Connecticut
      The Eye Center, Hamden,  Connecticut,  06518,  United States
Florida
      University of Florida, Gainesville,  Florida,  32610,  United States
Georgia
      Emory Healthcare Eye Center, Atlanta,  Georgia,  30322,  United States
      Omni Eye Services, Atlanta,  Georgia,  30342,  United States
Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States
      University of Illinois Eye and Ear Infirmary, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana University School of Medicine, Indianapolis,  Indiana,  46202,  United States
Massachusetts
      Glaucoma Consultation Service, Boston,  Massachusetts,  02114,  United States
Michigan
      Kresge Eye Institute, Detroit,  Michigan,  48201,  United States
Mississippi
      Mississippi Eye Associates, Ocean Springs,  Mississippi,  39564,  United States
New York
      Eyecare Ophthalmology PC, Bethpage,  New York,  11714,  United States
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States
Oklahoma
      Dean McGee Eye Institute, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      Wills Eye Institute, Philadelphia,  Pennsylvania,  19107,  United States
      The Keystone Eye Associates, Philadelphia,  Pennsylvania,  19114,  United States
Texas
      Hermann Eye Center, Houston,  Texas,  77030,  United States
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Glaucoma Associates of Texas, Dallas,  Texas,  75231,  United States
      Lone Star Eye Associates, Sugarland,  Texas,  77479,  United States
West Virginia
      West Virginia University Eye Institute, Morgantown,  West Virginia,  26506,  United States

Study chairs or principal investigators

Robert M Feldman, M.D.,  Study Chair,  Hermann Eye Fund / University of Texas   

Study ID Numbers:  HEF-042; Not Applicable
Last Updated:  August 1, 2005
Record first received:  July 13, 2005
ClinicalTrials.gov Identifier:  NCT00121147
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23