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Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Primary Purpose

Horner Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
10% phenylephrine
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Horner Syndrome focused on measuring Alpha blockers, Tamsulosin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Horner's Syndrome
  2. History of taking an alpha blocker (tamsulosin/ terazosin/doxazosin/alfuzosin/silodosin) medication

Exclusion Criteria:

  1. Subjects with untreated hypertension
  2. Subjects with thyrotoxicosis
  3. Pregnant women
  4. Prisoners
  5. Inability to consent
  6. Subjects with anatomical narrow angles who have never had a dilated exam

Sites / Locations

  • University of Colorado Hospital, Rocky Mountain Lions Eye Institute
  • Denver Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

10% phenylephrine

Arm Description

All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured.

Outcomes

Primary Outcome Measures

Pupil Size Measurements
pupil dilation measurements will be taken of each eye at the eye examination.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2018
Last Updated
February 18, 2022
Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03615508
Brief Title
Exploration of Pupil Dilation in Horner's Patients Taking Flomax
Official Title
Exploration of Pupil Dilation in Horner's Patients Taking Flomax
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
incomplete enrollment
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is evaluating the pupil dilation of Horner's Patients who have ever taken an alpha blocker such as Tamsulosin. Patients will undergo eye dilation as would occur at a yearly eye examination, but their pupil dilation measurements will be recorded.
Detailed Description
This study will enroll 10 participants who have a unilateral Horner's Syndrome AND have a history of taking an alpha blocker such as Tamsulosin. Participants will be recruited based on those two enrollment criteria, and after consenting they will undergo pupil dilation with 10% phenylephrine. Once fully dilated the pupil size will be measured. Pupil dilation size of the eye affected by the Horner's Syndrome will be compared to the eye not affected by Horner's. Primary study outcome is the comparative dilation size of the Horner's affected eye to the non affected eye in all subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horner Syndrome
Keywords
Alpha blockers, Tamsulosin

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Single arm, intervention trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10% phenylephrine
Arm Type
Other
Arm Description
All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured.
Intervention Type
Drug
Intervention Name(s)
10% phenylephrine
Other Intervention Name(s)
Phenylephrine 10%, Pupil Dilation
Intervention Description
10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation.
Primary Outcome Measure Information:
Title
Pupil Size Measurements
Description
pupil dilation measurements will be taken of each eye at the eye examination.
Time Frame
20-30 minutes after 10% phenylephrine has been placed in each eye.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Horner's Syndrome History of taking an alpha blocker (tamsulosin/ terazosin/doxazosin/alfuzosin/silodosin) medication Exclusion Criteria: Subjects with untreated hypertension Subjects with thyrotoxicosis Pregnant women Prisoners Inability to consent Subjects with anatomical narrow angles who have never had a dilated exam
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristos Ifantides, MD
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital, Rocky Mountain Lions Eye Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80023
Country
United States
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Exploration of Pupil Dilation in Horner's Patients Taking Flomax

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