Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

Benign Vascular Periocular Lesions Clinical Trial

Official title:

Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01250457
• Other study ID #: 202688
• Status: Withdrawn
• Phase: Phase 4
• First received: November 29, 2010
• Last updated: October 29, 2012
• Start date: June 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Vascular Periocular Lesions

Intervention

Drug:
• topical Timolol
topical Timolol 0.5% solution applied twice daily

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lesion resolution	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.	1 year	No