Viewing Study NCT01250457


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Study NCT ID: NCT01250457
Status: WITHDRAWN
Last Update Posted: 2012-10-30
First Post: 2010-11-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Topical Timolol for the Treatment of Benign Vascular Periocular Lesions
Sponsor: Loyola University
Organization:

Study Overview

Official Title: Topical Timolol for the Treatment of Benign Vascular Periocular Lesions
Status: WITHDRAWN
Status Verified Date: 2012-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Unknown, PI has left the institution. There was no enrollment.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this research is to find out if the use of topical timolol 0.5% solution applied twice daily will help to shrink rosacea lesions around the eye.
Detailed Description: Benign vascular tumors of the eyelid are common causes of ocular morbidity. Capillary hemangiomas in children cause refractive and occlusive amblyopia. In adults, Rosacea-associated eyelid telangiectasis and sclerosis can result in keratitis and corneal neovascularization. Corticosteroid therapy of benign vascular lesions risks sight-threatening complications including central retinal artery occlusion and significant systemic morbidity. Alternatively, oral and intravenous beta-blockers have been reported to induce regression of benign vascular lesions. One recent report documented efficacy of topical timolol in treating a large capillary hemangioma of the eyelid in a child. Topical application reduces systemic side effects of beta-blockers including bradycardia, hypotension, heart block, and bronchospasm. This one-year prospective case-control series will investigate whether topical Timolol 0.5% solution applied twice daily causes significant regression of benign vascular periocular lesions.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: