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

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension, Pseudoexfoliation Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Travatan
Azopt
Alphagan P
Sponsored by
Hermann Eye Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring glaucoma, pseudoexfoliation

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts 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 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

Sites / Locations

  • Doheny Eye Institute
  • The Eye Center
  • University of Florida
  • Emory Healthcare Eye Center
  • Omni Eye Services
  • Northwestern University
  • University of Illinois Eye and Ear Infirmary
  • Indiana University School of Medicine
  • Glaucoma Consultation Service
  • Kresge Eye Institute
  • Mississippi Eye Associates
  • Eyecare Ophthalmology PC
  • Mount Sinai School of Medicine
  • Dean McGee Eye Institute
  • Wills Eye Institute
  • The Keystone Eye Associates
  • Glaucoma Associates of Texas
  • Baylor College of Medicine
  • Hermann Eye Center
  • Lone Star Eye Associates
  • West Virginia University Eye Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
July 13, 2005
Last Updated
February 22, 2006
Sponsor
Hermann Eye Center
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00121147
Brief Title
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

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hermann Eye Center
Collaborators
Alcon Research

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension, Pseudoexfoliation Syndrome
Keywords
glaucoma, pseudoexfoliation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Travatan
Intervention Type
Drug
Intervention Name(s)
Azopt
Intervention Type
Drug
Intervention Name(s)
Alphagan P
Primary Outcome Measure Information:
Title
Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
Secondary Outcome Measure Information:
Title
Change in IOP from baseline at each time point
Title
IOP at 8AM (prior to dosing), 12 noon and 4 pm at month 3
Title
Percent IOP lowering from pretreatment baseline to the three month visit. Both diurnal average and at each time point
Title
Percent of patients reaching specific target pressures after three months of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Feldman, M.D.
Organizational Affiliation
Hermann Eye Fund / University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
Doheny Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-4666
Country
United States
Facility Name
The Eye Center
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory Healthcare Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Omni Eye Services
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois Eye and Ear Infirmary
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Glaucoma Consultation Service
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mississippi Eye Associates
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Eyecare Ophthalmology PC
City
Bethpage
State/Province
New York
ZIP/Postal Code
11714
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The Keystone Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hermann Eye Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lone Star Eye Associates
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
West Virginia University Eye Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

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

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