Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Summary
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
Study Design
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Conditions
Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Intervention
intravitreal brimonidine tartrate implant using Posterior Segment Drug Delivery System (PS DDS®) Applicator
Location
Artesia
California
United States
Status
Recruiting
Source
Allergan
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01080209
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Dental Implantation, Endosseous
Insertion of an implant into the bone of the mandible or maxilla. The implant has an exposed head which protrudes through the mucosa and is a prosthodontic abutment.
Posterior Eye Segment
The back two-thirds of the eye that includes the anterior hyaloid membrane and all of the optical structures behind it: the VITREOUS HUMOR; RETINA; CHOROID; and OPTIC NERVE.
Intravitreal Injections
The administration of substances into the VITREOUS BODY of the eye with a hypodermic syringe.
Immediate Dental Implant Loading
Endosseous dental implantation where implants are fitted with an abutment or where an implant with a transmucosal coronal portion is used immediately (within 1 week) after the initial extraction. Conventionally, the implantation is performed in two stages with more than two months in between the stages.
Hirschsprung Disease
Congenital MEGACOLON resulting from the absence of ganglion cells (aganglionosis) in a distal segment of the LARGE INTESTINE. The aganglionic segment is permanently contracted thus causing dilatation proximal to it. In most cases, the aganglionic segment is within the RECTUM and SIGMOID COLON.
Clinical Trials
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in...
Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes
The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.
The primary objective of this study is to compare the safety and efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular hypertension.
Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%
A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogu...
PubMed Articles
Drug delivery to the posterior segment of the eye.
Drug delivery into the posterior segment of the eye is complicated by the existence of the blood-ocular barrier. Strategies for delivering drugs to the posterior segment include systemic administratio...
Brimonidine Hypersensitivity when Switching Between 0.2% and 0.15% Formulations.
Abstract Purpose: To investigate hypersensitivity rates in patients switched from brimonidine-purite 0.15% to generic brimonidine 0.2%, and to then investigate hypersensitivity rates to re-initiated b...
Effects of brimonidine 0.2%-timolol 0.5% fixed-combination therapy for glaucoma.
PURPOSE: To evaluate the effects of brimonidine 0.2%-timolol 0.5% fixed-combination therapy in the treatment of patients with glaucoma. METHODS: To measure the main treatment effects of a fixed combin...
Pharmacokinetics and pharmacodynamics of the sustained-release dexamethasone intravitreal implant.
PURPOSE. To determine the pharmacokinetics and pharmacodynamics of the sustained-release dexamethasone (DEX) intravitreal implant (Ozurdex; Allergan, Inc.). METHODS. Thirty-four male Macaca fascicular...
In this study, nanovesicles were developed for brimonidine tartrate by film hydration technique and dispersed in viscous carbopol solution for ocular delivery. Scanning electron microscopy revealed sp...
