Exploration of Pupil Dilation in Horner's Patients Taking Flomax

• Sponsor: Denver Health and Hospital Authority (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03615508
• Collaborator: University of Colorado, Denver (Other)
• Enrollment: 1
• Locations: 2
• Arm: 1
• Actual Duration (Months): 7.3
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0.1

Study Details

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.

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

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single arm, intervention trial.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: Sep 21, 2018
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Phenylephrine 10%, Pupil Dilation

Outcome Measures

Primary Outcome Measures

1. Pupil Size Measurements [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital, Rocky Mountain Lions Eye Institute	Denver	Colorado	United States	80023
2	Denver Health	Denver	Colorado	United States	80024

Sponsors and Collaborators

• Denver Health and Hospital Authority
• University of Colorado, Denver

Investigators

• Principal Investigator: Cristos Ifantides, MD, Denver Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 17, 2020

More Information

Publications

None provided.

• 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: Aug 3, 2018
• Last Update Posted: Mar 3, 2022
• Last Verified: Feb 1, 2022

• 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, Associate Professor, Department of Ophthalmology, Denver Health and Hospital Authority: Alpha blockers; Tamsulosin
• Additional relevant MeSH terms: Horner Syndrome; Mydriasis; Phenylephrine; Oxymetazoline

Study Results

Participant Flow

Arm/Group Title	10% Phenylephrine
Arm/Group 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. 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.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	10% Phenylephrine
Arm/Group 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. 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.
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

Study incomplete. Only 1 subject enrolled and data not reported for 1 participant for privacy reasons.

Arm/Group Title	10% Phenylephrine
Arm/Group 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. 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.
Measure Participants	0

Adverse Events

Time Frame	N/A - Adverse Events not Monitored/Assessed
Adverse Event Reporting Description	Study not completed.
Arm/Group Title	10% Phenylephrine
Arm/Group 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. 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.
All Cause Mortality
	10% Phenylephrine
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	10% Phenylephrine
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	10% Phenylephrine
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.