The Effect of Lumify™ Eyedrops on Eyelid Position

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to see if Lumify™ has an effect on eyelid position.

Official Title
-----------------
The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height

Conditions
-----------------
Eyelid Droop

Intervention / Treatment
-----------------
* Drug: Brimonidine tartrate ophthalmic solution 0.025%
* Other: Sterile balanced saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Prisoners Pregnant women. Known contradictions or sensitivities to study medication (brimonidine) 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) Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 < 1mm) 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumify Eye Drop<br>Participants will be randomized to receive a single drop of Lumify to either the left or right eye. | Drug: Brimonidine tartrate ophthalmic solution 0.025%<br>* One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)<br>* Other names: Lumify;|
| Active Comparator: Saline Solution Eye Drop<br>Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye. | Other: Sterile balanced saline solution<br>* One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palpebral Fissure Height | Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs. | Baseline, 5, 15 and 30 minutes after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure | Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer | Baseline, 5, 15 and 30 minutes after application | 
| Eye Redness | Eye redness will be reported as the number of participants achieving a score of ocular redness from clinical photographs as 0 (none), 1 (mild), 2 (moderate) and 3 (severe). | Baseline, 5, 15 and 30 minutes after application | 
| Eye Discomfort | Eye discomfort will be reported as the number of participants reporting subjective ocular discomfort score from 0 (none), 1 (mild), 2 (mild) and 3 (severe). | Baseline, 5, 15 and 30 minutes after application |