Topical Timolol for the Treatment of Benign Vascular Periocular Lesions
Overview
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Loyola University
- Locations
- 1
- Primary Endpoint
- lesion resolution
Overview
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.
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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Topical timolol
topical Timolol 0.5% solution applied twice daily
Intervention: topical Timolol (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported