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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brimonidine Purite
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All subjects must: Be willing and able to provide written Informed Consent Be able and willing to follow instructions and likely to complete the entire course of the study. Be male or female of any race at least 18 years of age. Have visually significant cataract for which they have elected to undergo cataract surgery. Exclusion Criteria: No subject may: Known allergy or sensitivity to the study medication or its components Contraindications to brimonidine therapy: concurrent use of monoamine oxidase (MAO) inhibitor therapy 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. Any ocular surgery (including laser, refractive, intraocular filtering surgery, or any other ocular surgery) within 3 months. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears. 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. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception. 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)

Sites / Locations

  • University Hospital
  • Veterans Affairs Medical Center
  • Wishard Memorial Hospital
  • Iu Eye at Carmel

Outcomes

Primary Outcome Measures

Bioanalysis of brimonidine concentrations.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2006
Last Updated
October 16, 2007
Sponsor
Indiana University School of Medicine
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00352807
Brief Title
Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients
Official Title
Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University School of Medicine
Collaborators
Allergan

4. Oversight

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Brimonidine Purite
Primary Outcome Measure Information:
Title
Bioanalysis of brimonidine concentrations.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects must: Be willing and able to provide written Informed Consent Be able and willing to follow instructions and likely to complete the entire course of the study. Be male or female of any race at least 18 years of age. Have visually significant cataract for which they have elected to undergo cataract surgery. Exclusion Criteria: No subject may: Known allergy or sensitivity to the study medication or its components Contraindications to brimonidine therapy: concurrent use of monoamine oxidase (MAO) inhibitor therapy 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. Any ocular surgery (including laser, refractive, intraocular filtering surgery, or any other ocular surgery) within 3 months. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears. 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. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis B Cantor, MD
Organizational Affiliation
IUPUI/Clarian
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Iu Eye at Carmel
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background

Learn more about this trial

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

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