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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

Primary Purpose

Glaucoma

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Brimonidine

Placebo Lotion

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Brimonidine, Transdermal

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
Male or Female patients aged at least 18 years of age.
Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
Best-Corrected Visual Acuity of 20/800 or better in both eyes
Written informed consent.
Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.

Exclusion Criteria:

Uncontrolled glaucoma
Glaucoma requiring more than a single agent for IOP control
Patients with a corneal thickness greater then 620 micrometers
Female patients who are pregnant, nursing, or planning a pregnancy during the study
Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
Uncontrolled or labile hypertension
At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.

Sites / Locations

Eye Surgical and Medical AssociatesRecruiting

Outcomes

Primary Outcome Measures

Intraocular Pressure

Heart Rate

Blood Pressure

Intraocular Pressure

Heart Rate

Blood Pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT01345448

First Posted

April 27, 2011

Last Updated

April 28, 2011

Sponsor

Nanduri, Padma, M.D., FACS

1. Study Identification

Unique Protocol Identification Number

NCT01345448

Brief Title

Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

Official Title

Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

July 2011 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Nanduri, Padma, M.D., FACS

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid.

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects. Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.

6. Conditions and Keywords

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

Glaucoma

Keywords

Glaucoma, Brimonidine, Transdermal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Brimonidine

Other Intervention Name(s)

Alphagan

Intervention Description

0.1% Brimonidine Lotion, dosed once.

Intervention Type

Drug

Intervention Name(s)

Placebo Lotion

Intervention Description

Placebo Lotion dosed once.

Primary Outcome Measure Information:

Title

Intraocular Pressure

Time Frame

Day one, every hour for twelve hours.

Title

Heart Rate

Time Frame

Day one, every hour for twelve hours.

Title

Blood Pressure

Time Frame

Day one, every hour for twelve hours.

Title

Intraocular Pressure

Time Frame

Day two twice, once in the AM, once in the PM.

Title

Intraocular Pressure

Time Frame

Day seven, once.

Title

Intraocular Pressure

Time Frame

Day fourteen, once.

Title

Intraocular Pressure

Time Frame

Day twenty one, once.

Title

Intraocular Pressure

Time Frame

Day twenty eight, once.

Title

Heart Rate

Time Frame

Day two twice, once in the AM, once in the PM.

Title

Heart Rate

Time Frame

Day seven, once.

Title

Heart Rate

Time Frame

Day fourteen, once.

Title

Heart Rate

Time Frame

Day twenty one, once.

Title

Heart Rate

Time Frame

Day twenty eight, once.

Title

Blood Pressure

Time Frame

Day two twice, once in the AM, once in the PM.

Title

Blood Pressure

Time Frame

Day seven, once.

Title

Blood Pressure

Time Frame

Day fourteen, once.

Title

Blood Pressure

Time Frame

Day twenty one, once.

Title

Blood Pressure

Time Frame

Day twenty eight, once.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months. Male or Female patients aged at least 18 years of age. Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms. A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential Best-Corrected Visual Acuity of 20/800 or better in both eyes Written informed consent. Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site. Exclusion Criteria: Uncontrolled glaucoma Glaucoma requiring more than a single agent for IOP control Patients with a corneal thickness greater then 620 micrometers Female patients who are pregnant, nursing, or planning a pregnancy during the study Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study Uncontrolled or labile hypertension At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Boone, MD

Phone

(559)627-9393

drboone@visaliaeyecare.com

First Name & Middle Initial & Last Name or Official Title & Degree

Padma Nanduri, MD

Phone

858-450-1010

Ext

134

drnanduri@envisioneye.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Padma Nanduri, MD

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Boone, MD

Official's Role

Study Director

Facility Information:

Facility Name

Eye Surgical and Medical Associates

City

Visalia

State/Province

California

ZIP/Postal Code

93277

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Boone, MD

Phone

559-627-9393

drboone@visaliaeyecare.com

First Name & Middle Initial & Last Name & Degree

Amy Smith

Phone

(559)627-9393

amys@visaliaeyecare.com

First Name & Middle Initial & Last Name & Degree

Michael Boone, MD

12. IPD Sharing Statement

Learn more about this trial

Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

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