NCT01250457

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

2.1 years

First QC Date

November 29, 2010

Last Update Submit

October 29, 2012

Conditions

Benign Vascular Periocular Lesions

Outcome Measures

Primary Outcomes (1)

  • lesion resolution

    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.

    1 year

Study Arms (1)

Topical timolol

EXPERIMENTAL

topical Timolol 0.5% solution applied twice daily

Drug: topical Timolol

Interventions

topical TimololDRUG

topical Timolol 0.5% solution applied twice daily

Also known as: Timoptic
Topical timolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of a benign vascular periocular lesion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Interventions

Timolol

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • David Yoo, MD

    Loyola University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2010

First Posted

November 30, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

US(1)