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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine | Drug | 0.1% Brimonidine Lotion, dosed once. |
| |
| Placebo Lotion | Drug | Placebo Lotion dosed once. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | Day one, every hour for twelve hours. | |
| Heart Rate | Day one, every hour for twelve hours. | |
| Blood Pressure | Day one, every hour for twelve hours. | |
| Intraocular Pressure | Day two twice, once in the AM, once in the PM. | |
| Intraocular Pressure | Day seven, once. | |
| Intraocular Pressure | Day fourteen, once. | |
| Intraocular Pressure | Day twenty one, once. | |
| Intraocular Pressure | Day twenty eight, once. | |
| Heart Rate | Day two twice, once in the AM, once in the PM. | |
| Heart Rate | Day seven, once. | |
| Heart Rate | Day fourteen, once. | |
| Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Boone, MD | Contact | (559)627-9393 | drboone@visaliaeyecare.com | |
| Padma Nanduri, MD | Contact | 858-450-1010 | 134 | drnanduri@envisioneye.com |
| Name | Affiliation | Role |
|---|---|---|
| Padma Nanduri, MD | Principal Investigator | |
| Michael Boone, MD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Surgical and Medical Associates | Recruiting | Visalia | California | 93277 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Day twenty one, once. |
| Heart Rate | Day twenty eight, once. |
| Blood Pressure | Day two twice, once in the AM, once in the PM. |
| Blood Pressure | Day seven, once. |
| Blood Pressure | Day fourteen, once. |
| Blood Pressure | Day twenty one, once. |
| Blood Pressure | Day twenty eight, once. |