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Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

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ClinicalTrials.gov Identifier: NCT01250457
Recruitment Status : Withdrawn (Unknown, PI has left the institution. There was no enrollment.)
First Posted : November 30, 2010
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
Loyola University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Benign Vascular Periocular Lesions Drug: topical Timolol Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Timolol for the Treatment of Benign Vascular Periocular Lesions
Study Start Date : June 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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U.S. FDA Resources

Arms and Interventions
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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 Name: Timoptic


Outcome Measures
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Primary Outcome Measures :
  1. lesion resolution [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01250457     History of Changes
Other Study ID Numbers: 202688
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012

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