NCT00352807

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
Last Updated

October 17, 2007

Status Verified

October 1, 2007

First QC Date

July 14, 2006

Last Update Submit

October 16, 2007

Conditions

Cataract

Keywords

Cataract

Outcome Measures

Primary Outcomes (1)

  • Bioanalysis of brimonidine concentrations.

Interventions

Brimonidine PuriteDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital

Indianapolis, Indiana, 46202, United States

Location

Veterans Affairs Medical Center

Indianapolis, Indiana, 46202, United States

Location

Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

Iu Eye at Carmel

Indianapolis, Indiana, 46290, United States

Location

Related Publications (2)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Louis B Cantor, MD

    IUPUI/Clarian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 17, 2006

Study Start

February 1, 2005

Study Completion

December 1, 2005

Last Updated

October 17, 2007

Record last verified: 2007-10

Locations

US(4)