Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients

• ClinicalTrials.gov Identifier: NCT00352807
• Recruitment Status: Completed
• First Posted: July 17, 2006
• Last Update Posted: October 17, 2007
• Sponsor: Indiana University School of Medicine
• Collaborator: Allergan
• Information provided by: Indiana University

Study Description

Brief Summary:

The purpose of this study is to obtain and assay human aqueous samples following pre-operative dosing with 0.1% Brimonidine Purite™ (pH 7.8) or with 0.15% Brimonidine Purite® (pH 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous concentration of the two formulations.Study hypothesis: The aqueous humor concentration 45 minutes following dosing of 0.1% Brimonidine Purite™ (pH 7.8) is comparable with 0.15% Brimonidine Purite® (pH 7.2)

Condition or disease	Intervention/treatment	Phase
Cataract	Drug: Brimonidine Purite	Not Applicable

Detailed Description:

The purpose of this study is to obtain and assay human aqueous samples following pre-operative dosing with 0.1% Brimonidine Purite™ (pH 7.8) or with 0.15% Brimonidine Purite® (pH 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous concentration of the two formulations.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients.
• Study Start Date: February 2005
• Study Completion Date: December 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Bioanalysis of brimonidine concentrations.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• All subjects must:

  1. Be willing and able to provide written Informed Consent
  2. Be able and willing to follow instructions and likely to complete the entire course of the study.
  3. Be male or female of any race at least 18 years of age.
  4. Have visually significant cataract for which they have elected to undergo cataract surgery.

Exclusion Criteria:

• No subject may:

  1. Known allergy or sensitivity to the study medication or its components
  2. Contraindications to brimonidine therapy: concurrent use of monoamine oxidase (MAO) inhibitor therapy
  3. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator.
  4. Any ocular surgery (including laser, refractive, intraocular filtering surgery, or any other ocular surgery) within 3 months.
  5. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears.
  6. Have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior chamber which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator.
  7. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
  8. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception.
  9. Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study such as, significant cardiovascular disease, hepatic or renal impairment, depression, Raynaud's, orthostatic hypotension; uncontrolled high blood pressure. or concomitant use of other potential CNS depressants and tricyclics, (Amendment 1, May 25, 2005)

Contacts and Locations

Locations

United States, Indiana

University Hospital

Indianapolis, Indiana, United States, 46202

Veterans Affairs Medical Center

Indianapolis, Indiana, United States, 46202

Wishard Memorial Hospital

Indianapolis, Indiana, United States, 46202

Iu Eye at Carmel

Indianapolis, Indiana, United States, 46290

Sponsors and Collaborators

Indiana University School of Medicine

Allergan

Investigators

• Principal Investigator: Louis B Cantor, MD; IUPUI/Clarian

More Information

Publications:

PK-02-P027 Relative ocular bioavailability of 0.2% Alphagan and 0.15% Brimonidine-BAK to that of 0.15% Alphagan P in female albino rabbits. Allergan 2002.

PK-02-P041 Comparison of ocular and systemic bioavailability of three 0.10% brimonidine purite formulations to that of 0.15% Alphagan P in albino rabbits. Allergan 2002.

• ClinicalTrials.gov Identifier: NCT00352807
• Other Study ID Numbers: 0501-45
• First Posted: July 17, 2006
• Last Update Posted: October 17, 2007
• Last Verified: October 2007

Keywords provided by Indiana University:

Cataract

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases; Brimonidine Tartrate; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs