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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352807
• Other study ID #: 0501-45
• Status: Completed
• Phase: N/A
• First received: July 14, 2006
• Last updated: October 16, 2007
• Start date: February 2005
• Est. completion date: December 2005

Study information

• Verified date: October 2007
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Brimonidine Purite

Locations

Country	Name	City	State
United States	Iu Eye at Carmel	Indianapolis	Indiana
United States	University Hospital	Indianapolis	Indiana
United States	Veterans Affairs Medical Center	Indianapolis	Indiana
United States	Wishard Memorial Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Allergan

Country where clinical trial is conducted

United States, 

References & 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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioanalysis of brimonidine concentrations.