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Exploration of Pupil Dilation in Horner's Patients Taking Flomax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615508
Recruitment Status : Terminated (incomplete enrollment)
First Posted : August 3, 2018
Results First Posted : October 14, 2020
Last Update Posted : March 3, 2022
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Cristos Ifantides, MD, MBA, Denver Health and Hospital Authority

Study Description
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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.

Condition or disease Intervention/treatment Phase
Horner Syndrome Drug: 10% phenylephrine Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, intervention trial.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploration of Pupil Dilation in Horner's Patients Taking Flomax
Actual Study Start Date : September 21, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
10% phenylephrine
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.
 Drug: 10% phenylephrine
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.
Other Name: Phenylephrine 10%, Pupil Dilation


Outcome Measures
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Primary Outcome Measures :
  1. Pupil Size Measurements [ Time Frame: 20-30 minutes after 10% phenylephrine has been placed in each eye. ]
    pupil dilation measurements will be taken of each eye at the eye examination.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615508


Locations
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United States, Colorado
University of Colorado Hospital, Rocky Mountain Lions Eye Institute
Denver, Colorado, United States, 80023
Denver Health
Denver, Colorado, United States, 80024
Sponsors and Collaborators
Denver Health and Hospital Authority
University of Colorado, Denver
Investigators
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Principal Investigator: Cristos Ifantides, MD Denver Health
  Study Documents (Full-Text)

Documents provided by Cristos Ifantides, MD, MBA, Denver Health and Hospital Authority:
Study Protocol and Statistical Analysis Plan  [PDF] July 17, 2020

More Information
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Responsible Party: Cristos Ifantides, MD, MBA, Associate Professor, Department of Ophthalmology, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT03615508    
Other Study ID Numbers: COMIRB 18-0620
First Posted: August 3, 2018    Key Record Dates
Results First Posted: October 14, 2020
Last Update Posted: March 3, 2022
Last Verified: February 2022

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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
Keywords provided by Cristos Ifantides, MD, MBA, Denver Health and Hospital Authority:
Alpha blockers
Tamsulosin
Additional relevant MeSH terms:
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Horner Syndrome
Mydriasis
Pupil Disorders
Eye Diseases
Autonomic Nervous System Diseases
Nervous System Diseases
Miosis
Neurologic Manifestations
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents