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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

28 avril 2011 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Glaucome

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

Phase

Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- California
  - Visalia, California, États-Unis, 93277
    - Recrutement
    - Eye Surgical and Medical Associates
    - Contact:
      
      Michael Boone, MD
      
      Numéro de téléphone: 559-627-9393
      
      E-mail: drboone@visaliaeyecare.com
    - Contact:
      
      Amy Smith
      
      Numéro de téléphone: (559)627-9393
      
      E-mail: amys@visaliaeyecare.com
    - Sous-enquêteur:
      
      Michael Boone, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: Randomisé
Modèle interventionnel: Affectation parallèle
Masquage: Quadruple

Que mesure l'étude ?

Principaux critères de jugement

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nanduri, Padma, M.D., FACS

Les enquêteurs

Chercheur principal: Padma Nanduri, MD
Directeur d'études: Michael Boone, MD

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2011

Achèvement primaire (Anticipé)

1 juillet 2011

Achèvement de l'étude (Anticipé)