Eyelid Droop
Conditions
Brief summary
The purpose of the research is to see if Lumify™ has an effect on eyelid position.
Interventions
One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palpebral Fissure Height | Baseline, 5, 15 and 30 minutes after application | Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | Baseline, 5, 15 and 30 minutes after application | Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer |
| Eye Redness | Baseline, 5, 15 and 30 minutes after application | 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). |
| Eye Discomfort | Baseline, 5, 15 and 30 minutes after application | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 40 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 6 / 43 | 2 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Primary
Palpebral Fissure Height
Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
Time frame: Baseline, 5, 15 and 30 minutes after application
Population: All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution. Measurements from 3 participants were not collected due to brow ptosis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lumify Eye Drop | Palpebral Fissure Height | 15 minutes after application | 9.85 milimeter | Standard Deviation 1.42 |
| Lumify Eye Drop | Palpebral Fissure Height | Baseline | 9.64 milimeter | Standard Deviation 1.71 |
| Lumify Eye Drop | Palpebral Fissure Height | 30 minutes after application | 9.86 milimeter | Standard Deviation 1.32 |
| Lumify Eye Drop | Palpebral Fissure Height | 5 minutes after application | 9.92 milimeter | Standard Deviation 1.33 |
| Saline Solution Eye Drop | Palpebral Fissure Height | 30 minutes after application | 9.84 milimeter | Standard Deviation 1.26 |
| Saline Solution Eye Drop | Palpebral Fissure Height | Baseline | 9.66 milimeter | Standard Deviation 1.62 |
| Saline Solution Eye Drop | Palpebral Fissure Height | 15 minutes after application | 9.96 milimeter | Standard Deviation 1.4 |
| Saline Solution Eye Drop | Palpebral Fissure Height | 5 minutes after application | 9.96 milimeter | Standard Deviation 1.35 |
Secondary
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).
Time frame: Baseline, 5, 15 and 30 minutes after application
Population: All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lumify Eye Drop | Eye Discomfort | Baseline - None | 43 Participants |
| Lumify Eye Drop | Eye Discomfort | 15 minutes after application - none | 41 Participants |
| Lumify Eye Drop | Eye Discomfort | 5 minutes after application - none | 40 Participants |
| Lumify Eye Drop | Eye Discomfort | 15 minutes after application - mild | 1 Participants |
| Lumify Eye Drop | Eye Discomfort | Baseline - Moderate | 0 Participants |
| Lumify Eye Drop | Eye Discomfort | 15 minutes after application - moderate | 1 Participants |
| Lumify Eye Drop | Eye Discomfort | 5 minutes after application - mild | 3 Participants |
| Lumify Eye Drop | Eye Discomfort | 15 minutes after application - severe | 0 Participants |
| Lumify Eye Drop | Eye Discomfort | Baseline - Mild | 0 Participants |
| Lumify Eye Drop | Eye Discomfort | 30 minutes after application - none | 39 Participants |
| Lumify Eye Drop | Eye Discomfort | 5 minutes after application - moderate | 0 Participants |
| Lumify Eye Drop | Eye Discomfort | 30 minutes after application - mild | 4 Participants |
| Lumify Eye Drop | Eye Discomfort | Baseline - Severe | 0 Participants |
| Lumify Eye Drop | Eye Discomfort | 30 minutes after application - moderate | 0 Participants |
| Lumify Eye Drop | Eye Discomfort | 5 minutes after application - severe | 0 Participants |
| Lumify Eye Drop | Eye Discomfort | 30 minutes after application - severe | 0 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 5 minutes after application - severe | 1 Participants |
| Saline Solution Eye Drop | Eye Discomfort | Baseline - None | 43 Participants |
| Saline Solution Eye Drop | Eye Discomfort | Baseline - Mild | 0 Participants |
| Saline Solution Eye Drop | Eye Discomfort | Baseline - Moderate | 0 Participants |
| Saline Solution Eye Drop | Eye Discomfort | Baseline - Severe | 0 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 5 minutes after application - none | 38 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 5 minutes after application - mild | 4 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 5 minutes after application - moderate | 0 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 30 minutes after application - severe | 0 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 15 minutes after application - none | 40 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 15 minutes after application - mild | 2 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 15 minutes after application - moderate | 1 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 15 minutes after application - severe | 0 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 30 minutes after application - none | 40 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 30 minutes after application - mild | 3 Participants |
| Saline Solution Eye Drop | Eye Discomfort | 30 minutes after application - moderate | 0 Participants |
Secondary
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).
Time frame: Baseline, 5, 15 and 30 minutes after application
Population: All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lumify Eye Drop | Eye Redness | Baseline - None | 24 Participants |
| Lumify Eye Drop | Eye Redness | Baseline - Mild | 17 Participants |
| Lumify Eye Drop | Eye Redness | Baseline - Moderate | 2 Participants |
| Lumify Eye Drop | Eye Redness | Baseline - Severe | 0 Participants |
| Lumify Eye Drop | Eye Redness | 5 minutes after application - None | 38 Participants |
| Lumify Eye Drop | Eye Redness | 5 minutes after application - Mild | 4 Participants |
| Lumify Eye Drop | Eye Redness | 5 minutes after application - Moderate | 1 Participants |
| Lumify Eye Drop | Eye Redness | 5 minutes after application - Severe | 0 Participants |
| Lumify Eye Drop | Eye Redness | 15 minutes after application - None | 40 Participants |
| Lumify Eye Drop | Eye Redness | 15 minutes after application - Mild | 2 Participants |
| Lumify Eye Drop | Eye Redness | 15 minutes after application - Moderate | 1 Participants |
| Lumify Eye Drop | Eye Redness | 15 minutes after application - Severe | 0 Participants |
| Lumify Eye Drop | Eye Redness | 30 minutes after application - None | 41 Participants |
| Lumify Eye Drop | Eye Redness | 30 minutes after application - Mild | 1 Participants |
| Lumify Eye Drop | Eye Redness | 30 minutes after application - Moderate | 1 Participants |
| Lumify Eye Drop | Eye Redness | 30 minutes after application - Severe | 0 Participants |
| Saline Solution Eye Drop | Eye Redness | 30 minutes after application - Severe | 0 Participants |
| Saline Solution Eye Drop | Eye Redness | Baseline - None | 25 Participants |
| Saline Solution Eye Drop | Eye Redness | 15 minutes after application - None | 18 Participants |
| Saline Solution Eye Drop | Eye Redness | Baseline - Mild | 16 Participants |
| Saline Solution Eye Drop | Eye Redness | 30 minutes after application - None | 26 Participants |
| Saline Solution Eye Drop | Eye Redness | Baseline - Moderate | 2 Participants |
| Saline Solution Eye Drop | Eye Redness | 15 minutes after application - Mild | 24 Participants |
| Saline Solution Eye Drop | Eye Redness | Baseline - Severe | 0 Participants |
| Saline Solution Eye Drop | Eye Redness | 30 minutes after application - Moderate | 0 Participants |
| Saline Solution Eye Drop | Eye Redness | 5 minutes after application - None | 6 Participants |
| Saline Solution Eye Drop | Eye Redness | 15 minutes after application - Moderate | 1 Participants |
| Saline Solution Eye Drop | Eye Redness | 5 minutes after application - Mild | 19 Participants |
| Saline Solution Eye Drop | Eye Redness | 30 minutes after application - Mild | 17 Participants |
| Saline Solution Eye Drop | Eye Redness | 5 minutes after application - Moderate | 17 Participants |
| Saline Solution Eye Drop | Eye Redness | 15 minutes after application - Severe | 0 Participants |
| Saline Solution Eye Drop | Eye Redness | 5 minutes after application - Severe | 1 Participants |
Secondary
Intraocular Pressure
Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
Time frame: Baseline, 5, 15 and 30 minutes after application
Population: All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution. Intraocular Pressure was only conducted at Baseline and 30 minutes post application.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lumify Eye Drop | Intraocular Pressure | Baseline | 16.54 mmHg | Standard Deviation 3.63 |
| Lumify Eye Drop | Intraocular Pressure | 30 minutes after applciation | 15.54 mmHg | Standard Deviation 3.3 |
| Saline Solution Eye Drop | Intraocular Pressure | 30 minutes after applciation | 15.58 mmHg | Standard Deviation 2.99 |
| Saline Solution Eye Drop | Intraocular Pressure | Baseline | 16.70 mmHg | Standard Deviation 3.42 |