Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

This study has been withdrawn prior to enrollment.

(Unknown, PI has left the institution. There was no enrollment.)

Sponsor:

Information provided by (Responsible Party):

Loyola University

ClinicalTrials.gov Identifier:

NCT01250457

First received: November 29, 2010

Last updated: October 29, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Benign Vascular Periocular Lesions	Drug: topical Timolol	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

Resource links provided by NLM:

Drug Information available for: Timolol Timolol maleate

U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures:

lesion resolution [ Time Frame: 1 year ]
Pre-treatment and post-treatment lesion size will then be compared to determine whether twice-daily topical application of timolol 0.5% solution alters the morphometry of benign vascular periocular lesions.


Enrollment:	0
Study Start Date:	June 2010
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Topical timolol topical Timolol 0.5% solution applied twice daily	Drug: topical Timolol topical Timolol 0.5% solution applied twice daily Other Name: Timoptic

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Presence of a benign vascular periocular lesion

Exclusion Criteria:

Allergy to timolol or beta-blocker class of drugs
Lesion characteristics concerning for atypia or malignancy including madarosis, ulceration, and recurrence after previous surgery.
Intraocular Pressure less than 10 mm Hg

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01250457

Locations


United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153

Sponsors and Collaborators

Loyola University

Investigators


Principal Investigator:	David Yoo, MD	Loyola University

More Information


Responsible Party:	Loyola University
ClinicalTrials.gov Identifier:	NCT01250457 History of Changes
Other Study ID Numbers:	202688
Study First Received:	November 29, 2010
Last Updated:	October 29, 2012

Additional relevant MeSH terms:


Timolol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents

ClinicalTrials.gov processed this record on June 28, 2017

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