Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy
Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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California
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Visalia, California, Stati Uniti, 93277
- Reclutamento
- Eye Surgical and Medical Associates
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Contatto:
- Michael Boone, MD
- Numero di telefono: 559-627-9393
- Email: drboone@visaliaeyecare.com
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Contatto:
- Amy Smith
- Numero di telefono: (559)627-9393
- Email: amys@visaliaeyecare.com
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Sub-investigatore:
- Michael Boone, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Intraocular Pressure
Lasso di tempo: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Heart Rate
Lasso di tempo: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Blood Pressure
Lasso di tempo: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Intraocular Pressure
Lasso di tempo: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Intraocular Pressure
Lasso di tempo: Day seven, once.
|
Day seven, once.
|
|
Intraocular Pressure
Lasso di tempo: Day fourteen, once.
|
Day fourteen, once.
|
|
Intraocular Pressure
Lasso di tempo: Day twenty one, once.
|
Day twenty one, once.
|
|
Intraocular Pressure
Lasso di tempo: Day twenty eight, once.
|
Day twenty eight, once.
|
|
Heart Rate
Lasso di tempo: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Heart Rate
Lasso di tempo: Day seven, once.
|
Day seven, once.
|
|
Heart Rate
Lasso di tempo: Day fourteen, once.
|
Day fourteen, once.
|
|
Heart Rate
Lasso di tempo: Day twenty one, once.
|
Day twenty one, once.
|
|
Heart Rate
Lasso di tempo: Day twenty eight, once.
|
Day twenty eight, once.
|
|
Blood Pressure
Lasso di tempo: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Blood Pressure
Lasso di tempo: Day seven, once.
|
Day seven, once.
|
|
Blood Pressure
Lasso di tempo: Day fourteen, once.
|
Day fourteen, once.
|
|
Blood Pressure
Lasso di tempo: Day twenty one, once.
|
Day twenty one, once.
|
|
Blood Pressure
Lasso di tempo: Day twenty eight, once.
|
Day twenty eight, once.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Padma Nanduri, MD
- Direttore dello studio: Michael Boone, MD
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie degli occhi
- Ipertensione oculare
- Glaucoma
- Effetti fisiologici delle droghe
- Agenti adrenergici
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti antipertensivi
- Agonisti del recettore adrenergico alfa-2
- Alfa-agonisti adrenergici
- Agonisti adrenergici
- Brimonidina Tartrato
Altri numeri di identificazione dello studio
- White Rabbit 2010-0001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .