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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 0.005% Latanoprost 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 |
|---|---|---|---|---|
| 0.005% Latanoprost dosed once. | Drug | 0.005% Latanoprost dosed once. Placebo lotion dosed once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | Change in Intraocular Pressure from baseline. | Day one, every hour for twelve hours. |
| Intraocular Pressure | Change in Intraocular Pressure from baseline. | Day two twice, once in the AM, once in the PM. |
| Intraocular Pressure | Change in Intraocular Pressure from baseline. | Day nine, once. |
| Intraocular Pressure | Change in Intraocular Pressure from baseline. | Day sixteen, once. |
| Intraocular Pressure | Change in Intraocular Pressure from baseline. | Day twenty three, once. |
| Intraocular Pressure | Change in Intraocular Pressure from baseline. | Day thirty, once. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Padma Nanduri, MD | Contact | 858-699-4000 | drnanduri@envisioneye.com | |
| Aaron Dyer | Contact | 858-699-4000 | aaron@envisioneye.com |
| Name | Affiliation | Role |
|---|---|---|
| Padma Nanduri, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Surgical and Medical Associates | 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 |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |