A Phase 4 interventional study of 10% phenylephrine in Horner Syndrome, sponsored by Denver Health and Hospital Authority. Terminated at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Denver Health and Hospital Authority · Phase 4, Interventional, and Other
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.
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.
Exclusion Criteria:
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.
Also known as: Phenylephrine 10%, Pupil Dilation
Pupil Size Measurements
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.
| Milestone | 10% Phenylephrine |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
pupil dilation measurements will be taken of each eye at the eye examination.
No measurements were reported for this outcome.
Collected over N/A - Adverse Events not Monitored/Assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10% Phenylephrine | — | — | — |
Study terminated, no patients analyzed; Data not reported for 1 participant for privacy reasons.
| Age, Categorical | 10% Phenylephrine |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous | 10% Phenylephrine |
|---|
| Sex: Female, Male | 10% Phenylephrine |
|---|---|
| Female | — |
| Male | — |
| Race and Ethnicity Not Collected | 10% Phenylephrine |
|---|
| Region of Enrollment(participants) | 10% Phenylephrine |
|---|
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Horner Syndrome
Denver Health and Hospital Authority