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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

28 april 2011 bijgewerkt door: Nanduri, Padma, M.D., FACS

Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Glaucoom

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- California
  - Visalia, California, Verenigde Staten, 93277
    - Werving
    - Eye Surgical and Medical Associates
    - Contact:
      
      Michael Boone, MD
      
      Telefoonnummer: 559-627-9393
      
      E-mail: drboone@visaliaeyecare.com
    - Contact:
      
      Amy Smith
      
      Telefoonnummer: (559)627-9393
      
      E-mail: amys@visaliaeyecare.com
    - Onderonderzoeker:
      
      Michael Boone, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Verviervoudigen

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Intraocular Pressure Tijdsspanne: Day one, every hour for twelve hours.	Day one, every hour for twelve hours.
Heart Rate Tijdsspanne: Day one, every hour for twelve hours.	Day one, every hour for twelve hours.
Blood Pressure Tijdsspanne: Day one, every hour for twelve hours.	Day one, every hour for twelve hours.
Intraocular Pressure Tijdsspanne: Day two twice, once in the AM, once in the PM.	Day two twice, once in the AM, once in the PM.
Intraocular Pressure Tijdsspanne: Day seven, once.	Day seven, once.
Intraocular Pressure Tijdsspanne: Day fourteen, once.	Day fourteen, once.
Intraocular Pressure Tijdsspanne: Day twenty one, once.	Day twenty one, once.
Intraocular Pressure Tijdsspanne: Day twenty eight, once.	Day twenty eight, once.
Heart Rate Tijdsspanne: Day two twice, once in the AM, once in the PM.	Day two twice, once in the AM, once in the PM.
Heart Rate Tijdsspanne: Day seven, once.	Day seven, once.
Heart Rate Tijdsspanne: Day fourteen, once.	Day fourteen, once.
Heart Rate Tijdsspanne: Day twenty one, once.	Day twenty one, once.
Heart Rate Tijdsspanne: Day twenty eight, once.	Day twenty eight, once.
Blood Pressure Tijdsspanne: Day two twice, once in the AM, once in the PM.	Day two twice, once in the AM, once in the PM.
Blood Pressure Tijdsspanne: Day seven, once.	Day seven, once.
Blood Pressure Tijdsspanne: Day fourteen, once.	Day fourteen, once.
Blood Pressure Tijdsspanne: Day twenty one, once.	Day twenty one, once.
Blood Pressure Tijdsspanne: Day twenty eight, once.	Day twenty eight, once.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nanduri, Padma, M.D., FACS

Onderzoekers

Hoofdonderzoeker: Padma Nanduri, MD
Studie directeur: Michael Boone, MD

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2011

Primaire voltooiing (Verwacht)

1 juli 2011

Studie voltooiing (Verwacht)