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| Sponsor: | Loyola University |
|---|---|
| Information provided by (Responsible Party): | Loyola University |
| ClinicalTrials.gov Identifier: | NCT01250457 |
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 |
| Estimated Enrollment: | 111 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Yoo, MD | 708-216-3833 | DAYOO@lumc.edu |
| United States, Illinois | |
| Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Raymond Areaux, MD 708-216-3408 rareaux@lumc.edu | |
| Principal Investigator: David Yoo, MD | |
| Principal Investigator: | David Yoo, MD | Loyola University |
More Information
| Responsible Party: | Loyola University |
| ClinicalTrials.gov Identifier: | NCT01250457 History of Changes |
| Other Study ID Numbers: | 202688 |
| Study First Received: | November 29, 2010 |
| Last Updated: | September 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Timolol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents |