Exploration of Pupil Dilation in Horner's Patients Taking Flomax

NCT03615508 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: COMIRB 18-0620
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Horner Syndrome

Keywords

Alpha blockers; Tamsulosin

Outcome Measures

Primary Outcomes (1)

• Pupil Size Measurements

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

  20-30 minutes after 10% phenylephrine has been placed in each eye.

Study Arms (1)

10% phenylephrine

OTHER

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

Interventions

10% phenylephrine DRUG

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.

Also known as: Phenylephrine 10%, Pupil Dilation

10% phenylephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• University of Colorado, Denver: collaborator

Study Sites (2)

University of Colorado Hospital, Rocky Mountain Lions Eye Institute

Denver, Colorado, 80023, United States

Location

Denver Health

Denver, Colorado, 80024, United States

Location

MeSH Terms

Conditions

Horner Syndrome

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Cavernous Sinus Syndromes; Brain Diseases; Central Nervous System Diseases; Miosis; Pupil Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr. Ifantides
• Organization: Denver Health

cristos.ifantides@dhha.org

303-602-0156

Study Officials

• Cristos Ifantides, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Ophthalmology

Model Details: Single arm, intervention trial.

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 3, 2018
• Study Start: September 21, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 3, 2022
• Results First Posted: October 14, 2020

Record last verified: 2022-02

Locations

US (2)