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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121147
• Other study ID #: HEF-042
• Status: Completed
• Phase: N/A
• First received: July 13, 2005
• Last updated: February 22, 2006
• Start date: September 2003
• Est. completion date: October 2005

Study information

• Verified date: July 2005
• Source: Hermann Eye Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma
• Pseudoexfoliation Syndrome

Intervention

Drug:
• Travatan

• Azopt

• Alphagan P

Locations

Country	Name	City	State
United States	Emory Healthcare Eye Center	Atlanta	Georgia
United States	Omni Eye Services	Atlanta	Georgia
United States	Eyecare Ophthalmology PC	Bethpage	New York
United States	Glaucoma Consultation Service	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	University of Illinois Eye and Ear Infirmary	Chicago	Illinois
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Kresge Eye Institute	Detroit	Michigan
United States	University of Florida	Gainesville	Florida
United States	The Eye Center	Hamden	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	Hermann Eye Center	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Doheny Eye Institute	Los Angeles	California
United States	West Virginia University Eye Institute	Morgantown	West Virginia
United States	Mount Sinai School of Medicine	New York	New York
United States	Mississippi Eye Associates	Ocean Springs	Mississippi
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma
United States	The Keystone Eye Associates	Philadelphia	Pennsylvania
United States	Wills Eye Institute	Philadelphia	Pennsylvania
United States	Lone Star Eye Associates	Sugarland	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Hermann Eye Center	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
Secondary	Change in IOP from baseline at each time point
Secondary	IOP at 8AM (prior to dosing), 12 noon and 4 pm at month 3
Secondary	Percent IOP lowering from pretreatment baseline to the three month visit. Both diurnal average and at each time point
Secondary	Percent of patients reaching specific target pressures after three months of treatment.