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Trial record 2 of 3 for:    "Exfoliation Syndrome" | "Carbonic Anhydrase Inhibitors"

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

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ClinicalTrials.gov Identifier: NCT00121147
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : February 24, 2006
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Hermann Eye Center

Tracking Information
First Submitted Date  ICMJE July 13, 2005
First Posted Date  ICMJE July 21, 2005
Last Update Posted Date February 24, 2006
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00121147 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Open Angle Glaucoma
  • Ocular Hypertension
  • Pseudoexfoliation Syndrome
Intervention  ICMJE
  • Drug: Travatan
  • Drug: Azopt
  • Drug: Alphagan P
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 19, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00121147
Other Study ID Numbers  ICMJE HEF-042
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hermann Eye Center
Collaborators  ICMJE Alcon Research
Investigators  ICMJE
Study Chair: Robert M Feldman, M.D. Hermann Eye Fund / University of Texas
PRS Account Hermann Eye Center
Verification Date July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP