Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

Phase 4

Withdrawn

• Conditions: Benign Vascular Periocular Lesions
• Interventions: Drug: topical Timolol

• Registration Number: NCT01250457
• Lead Sponsor: Loyola University

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-29
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical timolol	topical Timolol	topical Timolol 0.5% solution applied twice daily

Primary Outcome Measures

Name	Time	Method
lesion resolution	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.

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States