Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

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.

Study Overview

• Status: Withdrawn
• Conditions: Benign Vascular Periocular Lesions
• Intervention / Treatment: Drug: topical Timolol

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical timolol; topical Timolol 0.5% solution applied twice daily	Drug: topical Timolol; topical Timolol 0.5% solution applied twice daily; Other Names: Timoptic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Loyola University
• Investigators: Principal Investigator: David Yoo, MD, Loyola University

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: November 29, 2010
• First Posted (Estimate): November 30, 2010

Study Record Updates

• Last Update Posted (Estimate): October 30, 2012
• Last Update Submitted That Met QC Criteria: October 29, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol
• Other Study ID Numbers: 202688