The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance

Study Overview
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Brief Summary
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The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.

Official Title
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The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance

Conditions
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Ptosis, Eyelid, Conjunctiva Inflamed, Eye Manifestations

Intervention / Treatment
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* Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age 18 and above able to provide informed consent to participate Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention Exclusion Criteria: Adults unable to consent Individuals less than 18 years of age Prisoners Pregnant women. Known contradictions or sensitivities to study medication (oxymetazoline) Ocular surgery within the past 3 months or refractive surgery within the past six months Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm) Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters Presence of an active ocular infection Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents Inability to sit comfortably for 15 - 30 minutes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upneeq Group<br>Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) | Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution<br>* One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.<br>* Other names: Upneeq;|
| Sham Comparator: Control Group<br>Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) | Drug: Placebo<br>* One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.<br>* Other names: Balanced saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Palpebral Fissure Height | Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation. | Baseline, Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale | Scoring of ocular redness from clinical photographs will be performed by investigators on a 10 - 100 unit scale as compared to standardized reference photographs per the Validated Bulbar Redness grading scale (10 = minimal redness, 100 = very red) before and after drop instillation. Higher score indicates more redness. | Baseline, Day 1 | 
| Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance | Change in patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall eye appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with eye appearance. | Baseline, Day 1 | 
| Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance | Change in patient-reported upper eyelid appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall upper eyelid appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with upper eyelid appearance. | Baseline, Day 1 |