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Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

NCT ID: NCT01250457

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Benign Vascular Periocular Lesions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical timolol

topical Timolol 0.5% solution applied twice daily

Group Type EXPERIMENTAL

topical Timolol

Intervention Type DRUG

topical Timolol 0.5% solution applied twice daily

Interventions

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topical Timolol

topical Timolol 0.5% solution applied twice daily

Intervention Type DRUG

Other Intervention Names

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Timoptic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loyola University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

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Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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202688

Identifier Type: -

Identifier Source: org_study_id