Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan

Condition(s) targeted: Open Angle Glaucoma; Ocular Hypertension; Pseudoexfoliation Syndrome

Intervention: Travatan (Drug); Azopt (Drug); Alphagan P (Drug)

Phase: N/A

Status: Completed

Sponsored by: Hermann Eye Center

Official(s) and/or principal investigator(s):
Robert M Feldman, M.D., Study Chair, Affiliation: Hermann Eye Fund / University of Texas

The purpose of this study is to compare the 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit

Secondary outcome:

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.

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.

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

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

Doheny Eye Institute, Los Angeles, California 90033-4666, United States

The Eye Center, Hamden, Connecticut 06518, United States

University of Florida, Gainesville, Florida 32610, United States

Emory Healthcare Eye Center, Atlanta, Georgia 30322, United States

Omni Eye Services, Atlanta, Georgia 30342, United States

Northwestern University, Chicago, Illinois 60611, United States

University of Illinois Eye and Ear Infirmary, Chicago, Illinois 60612, United States

Indiana University School of Medicine, Indianapolis, Indiana 46202, United States

Glaucoma Consultation Service, Boston, Massachusetts 02114, United States

Kresge Eye Institute, Detroit, Michigan 48201, United States

Mississippi Eye Associates, Ocean Springs, Mississippi 39564, United States

Eyecare Ophthalmology PC, Bethpage, New York 11714, United States

Mount Sinai School of Medicine, New York, New York 10029, United States

Dean McGee Eye Institute, Oklahoma City, Oklahoma 73104, United States

The Keystone Eye Associates, Philadelphia, Pennsylvania 19114, United States

Wills Eye Institute, Philadelphia, Pennsylvania 19107, United States

Glaucoma Associates of Texas, Dallas, Texas 75231, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Hermann Eye Center, Houston, Texas 77030, United States

Lone Star Eye Associates, Sugarland, Texas 77479, United States

West Virginia University Eye Institute, Morgantown, West Virginia 26506, United States

Starting date: September 2003
Last updated: February 22, 2006