Conjunctiva Inflamed, Eye Manifestations, Ptosis, Eyelid
Conditions
Brief summary
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.
Interventions
DRUGOxymetazoline hydrochloride 0.1% ophthalmic solution
One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.
DRUGPlacebo
One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Palpebral Fissure Height | Baseline, Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale | Baseline, Day 1 | 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. |
| Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance | Baseline, Day 1 | 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. |
| Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance | Baseline, Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Upneeq Group 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)
Oxymetazoline hydrochloride 0.1% ophthalmic solution: One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye. | 57 |
| Control Group 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)
Placebo: One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye. | 57 |
| Total | 114 |
Baseline characteristics
| Characteristic | Control Group | Total | Upneeq Group |
|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 10.1 | 33.9 years STANDARD_DEVIATION 11.4 | 36.4 years STANDARD_DEVIATION 12.7 |
| Eye Redness | 12.1 units on a scale STANDARD_DEVIATION 4.1 | 12.6 units on a scale STANDARD_DEVIATION 4.4 | 13.2 units on a scale STANDARD_DEVIATION 4.7 |
| FACE-Q Eye Appearance | 22.7 units on a scale STANDARD_DEVIATION 4.1 | 21.9 units on a scale STANDARD_DEVIATION 4.4 | 21.2 units on a scale STANDARD_DEVIATION 4.7 |
| FACE-Q Upper Eyelid Appearance | 24.3 units on a scale STANDARD_DEVIATION 4.7 | 23.8 units on a scale STANDARD_DEVIATION 5.2 | 23.4 units on a scale STANDARD_DEVIATION 5.8 |
| Palpebral Fissure | 10.5 mm STANDARD_DEVIATION 1.7 | 10.3 mm STANDARD_DEVIATION 1.6 | 10.1 mm STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 39 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 68 Participants | 40 Participants |
| Sex: Female, Male Female | 38 Participants | 77 Participants | 39 Participants |
| Sex: Female, Male Male | 19 Participants | 37 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 |
| other Total, other adverse events | 7 / 57 | 5 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
Primary
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.
Time frame: Baseline, Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Upneeq Group | Change in Palpebral Fissure Height | 1.1 mm | Standard Deviation 1.1 |
| Control Group | Change in Palpebral Fissure Height | -0.4 mm | Standard Deviation 0.8 |
Secondary
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.
Time frame: Baseline, Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Upneeq Group | Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale | -2.6 units on a scale | Standard Deviation 4.4 |
| Control Group | Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale | -0.5 units on a scale | Standard Deviation 2.3 |
Secondary
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.
Time frame: Baseline, Day 1
Population: One control patient declined completion of FACE-Q survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Upneeq Group | Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance | 4.2 score on a scale | Standard Deviation 5.4 |
| Control Group | Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance | 0.8 score on a scale | Standard Deviation 3.8 |
Secondary
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.
Time frame: Baseline, Day 1
Population: One control patient declined completion of FACE-Q survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Upneeq Group | Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance | 0.9 score on a scale | Standard Deviation 4.9 |
| Control Group | Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance | -0.5 score on a scale | Standard Deviation 4.8 |