Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

NCT ID: NCT01345448

Last Updated: 2011-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-07-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

Brimonidine

0.1% Brimonidine Lotion, dosed once.

Intervention Type: DRUG

Placebo Lotion

Placebo Lotion dosed once.

Intervention Type: DRUG

Other Intervention Names

Alphagan

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanduri, Padma, M.D., FACS

INDIV

Sponsor Role: lead

Responsible Party

Padma Nanduri, M.D., F.A.C.S.

Principal Investigators

Padma Nanduri, MD

Role: PRINCIPAL_INVESTIGATOR

Michael Boone, MD

Role: STUDY_DIRECTOR

Locations

Eye Surgical and Medical Associates

Visalia, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Boone, MD

Role: CONTACT

drboone@visaliaeyecare.com

(559)627-9393

Padma Nanduri, MD

Role: CONTACT

drnanduri@envisioneye.com

858-450-1010 ext. 134

Facility Contacts

Michael Boone, MD

Role: primary

drboone@visaliaeyecare.com

559-627-9393

Amy Smith

Role: backup

amys@visaliaeyecare.com

(559)627-9393

Other Identifiers

White Rabbit 2010-0001

Identifier Type: -

Identifier Source: org_study_id