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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00121147
Other study ID # HEF-042
Secondary ID
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
Est. primary completion date
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


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.
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