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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This study has been withdrawn prior to enrollment.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
  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: Endpoint Classification: Efficacy Study
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:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • lesion resolution [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Timolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014