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

Hermann Eye Center (Other)
Overall Status
Completed ID
Alcon Research (Industry)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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

Study Type:
Intervention Model:
Parallel Assignment
Primary Purpose:
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 Start Date :
Sep 1, 2003
Study Completion Date :
Oct 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit []

Secondary Outcome Measures

  1. Change in IOP from baseline at each time point []

  2. IOP at 8AM (prior to dosing), 12 noon and 4 pm at month 3 []

  3. Percent IOP lowering from pretreatment baseline to the three month visit. Both diurnal average and at each time point []

  4. Percent of patients reaching specific target pressures after three months of treatment. []

Eligibility Criteria


Ages Eligible for Study:
35 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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


  • 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

  • Use of any investigational medication within one month prior to baseline visit

Contacts and Locations


Site City State Country Postal Code
1 Doheny Eye Institute Los Angeles California United States 90033-4666
2 The Eye Center Hamden Connecticut United States 06518
3 University of Florida Gainesville Florida United States 32610
4 Emory Healthcare Eye Center Atlanta Georgia United States 30322
5 Omni Eye Services Atlanta Georgia United States 30342
6 Northwestern University Chicago Illinois United States 60611
7 University of Illinois Eye and Ear Infirmary Chicago Illinois United States 60612
8 Indiana University School of Medicine Indianapolis Indiana United States 46202
9 Glaucoma Consultation Service Boston Massachusetts United States 02114
10 Kresge Eye Institute Detroit Michigan United States 48201
11 Mississippi Eye Associates Ocean Springs Mississippi United States 39564
12 Eyecare Ophthalmology PC Bethpage New York United States 11714
13 Mount Sinai School of Medicine New York New York United States 10029
14 Dean McGee Eye Institute Oklahoma City Oklahoma United States 73104
15 Wills Eye Institute Philadelphia Pennsylvania United States 19107
16 The Keystone Eye Associates Philadelphia Pennsylvania United States 19114
17 Glaucoma Associates of Texas Dallas Texas United States 75231
18 Baylor College of Medicine Houston Texas United States 77030
19 Hermann Eye Center Houston Texas United States 77030
20 Lone Star Eye Associates Sugarland Texas United States 77479
21 West Virginia University Eye Institute Morgantown West Virginia United States 26506

Sponsors and Collaborators

  • Hermann Eye Center
  • Alcon Research


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
, , Identifier:
Other Study ID Numbers:
  • HEF-042
First Posted:
Jul 21, 2005
Last Update Posted:
Feb 24, 2006
Last Verified:
Jul 1, 2005

Study Results

No Results Posted as of Feb 24, 2006