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Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

Sponsor
Loyola University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01250457
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
25
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
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 :
Jun 1, 2010
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. lesion resolution [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Loyola University Medical Center Maywood Illinois United States 60153

    Sponsors and Collaborators

    • Loyola University

    Investigators

    • Principal Investigator: David Yoo, MD, Loyola University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Loyola University
    ClinicalTrials.gov Identifier:
    NCT01250457
    Other Study ID Numbers:
    • 202688
    First Posted:
    Nov 30, 2010
    Last Update Posted:
    Oct 30, 2012
    Last Verified:
    Oct 1, 2012
    Additional relevant MeSH terms:
    Timolol

    Study Results

    No Results Posted as of Oct 30, 2012