Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy
Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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California
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Visalia, California, Spojené státy, 93277
- Nábor
- Eye Surgical and Medical Associates
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Kontakt:
- Michael Boone, MD
- Telefonní číslo: 559-627-9393
- E-mail: drboone@visaliaeyecare.com
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Kontakt:
- Amy Smith
- Telefonní číslo: (559)627-9393
- E-mail: amys@visaliaeyecare.com
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Dílčí vyšetřovatel:
- Michael Boone, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Intraocular Pressure
Časové okno: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Heart Rate
Časové okno: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Blood Pressure
Časové okno: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Intraocular Pressure
Časové okno: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Intraocular Pressure
Časové okno: Day seven, once.
|
Day seven, once.
|
|
Intraocular Pressure
Časové okno: Day fourteen, once.
|
Day fourteen, once.
|
|
Intraocular Pressure
Časové okno: Day twenty one, once.
|
Day twenty one, once.
|
|
Intraocular Pressure
Časové okno: Day twenty eight, once.
|
Day twenty eight, once.
|
|
Heart Rate
Časové okno: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Heart Rate
Časové okno: Day seven, once.
|
Day seven, once.
|
|
Heart Rate
Časové okno: Day fourteen, once.
|
Day fourteen, once.
|
|
Heart Rate
Časové okno: Day twenty one, once.
|
Day twenty one, once.
|
|
Heart Rate
Časové okno: Day twenty eight, once.
|
Day twenty eight, once.
|
|
Blood Pressure
Časové okno: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Blood Pressure
Časové okno: Day seven, once.
|
Day seven, once.
|
|
Blood Pressure
Časové okno: Day fourteen, once.
|
Day fourteen, once.
|
|
Blood Pressure
Časové okno: Day twenty one, once.
|
Day twenty one, once.
|
|
Blood Pressure
Časové okno: Day twenty eight, once.
|
Day twenty eight, once.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Padma Nanduri, MD
- Ředitel studie: Michael Boone, MD
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- White Rabbit 2010-0001
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