Trial Outcomes & Findings for The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance (NCT NCT04831047)
NCT ID: NCT04831047
Last Updated: 2023-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
114 participants
Primary outcome timeframe
Baseline, Day 1
Results posted on
2023-04-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient did not complete FACE-Q survey in control group
Baseline characteristics by cohort
| Measure |
Upneeq Group
n=57 Participants
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.
|
Control Group
n=57 Participants
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.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 12.7 • n=57 Participants
|
31.3 years
STANDARD_DEVIATION 10.1 • n=57 Participants
|
33.9 years
STANDARD_DEVIATION 11.4 • n=114 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=57 Participants
|
38 Participants
n=57 Participants
|
77 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=57 Participants
|
19 Participants
n=57 Participants
|
37 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=57 Participants
|
26 Participants
n=57 Participants
|
39 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=57 Participants
|
3 Participants
n=57 Participants
|
7 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=57 Participants
|
28 Participants
n=57 Participants
|
68 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=114 Participants
|
|
Palpebral Fissure
|
10.1 mm
STANDARD_DEVIATION 1.5 • n=57 Participants
|
10.5 mm
STANDARD_DEVIATION 1.7 • n=57 Participants
|
10.3 mm
STANDARD_DEVIATION 1.6 • n=114 Participants
|
|
Eye Redness
|
13.2 units on a scale
STANDARD_DEVIATION 4.7 • n=57 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 4.1 • n=57 Participants
|
12.6 units on a scale
STANDARD_DEVIATION 4.4 • n=114 Participants
|
|
FACE-Q Eye Appearance
|
21.2 units on a scale
STANDARD_DEVIATION 4.7 • n=57 Participants • One patient did not complete FACE-Q survey in control group
|
22.7 units on a scale
STANDARD_DEVIATION 4.1 • n=56 Participants • One patient did not complete FACE-Q survey in control group
|
21.9 units on a scale
STANDARD_DEVIATION 4.4 • n=113 Participants • One patient did not complete FACE-Q survey in control group
|
|
FACE-Q Upper Eyelid Appearance
|
23.4 units on a scale
STANDARD_DEVIATION 5.8 • n=57 Participants • One patient did not complete FACE-Q survey in control group
|
24.3 units on a scale
STANDARD_DEVIATION 4.7 • n=56 Participants • One patient did not complete FACE-Q survey in control group
|
23.8 units on a scale
STANDARD_DEVIATION 5.2 • n=113 Participants • One patient did not complete FACE-Q survey in control group
|
PRIMARY outcome
Timeframe: Baseline, Day 1Palpebral 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.
Outcome measures
| Measure |
Upneeq Group
n=57 Participants
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.
|
Control Group
n=57 Participants
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.
|
|---|---|---|
|
Change in Palpebral Fissure Height
|
1.1 mm
Standard Deviation 1.1
|
-0.4 mm
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, Day 1Scoring 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.
Outcome measures
| Measure |
Upneeq Group
n=57 Participants
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.
|
Control Group
n=57 Participants
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.
|
|---|---|---|
|
Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale
|
-2.6 units on a scale
Standard Deviation 4.4
|
-0.5 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline, Day 1Population: One control patient declined completion of FACE-Q survey.
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.
Outcome measures
| Measure |
Upneeq Group
n=57 Participants
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.
|
Control Group
n=56 Participants
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.
|
|---|---|---|
|
Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance
|
4.2 score on a scale
Standard Deviation 5.4
|
0.8 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, Day 1Population: One control patient declined completion of FACE-Q survey
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.
Outcome measures
| Measure |
Upneeq Group
n=57 Participants
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.
|
Control Group
n=56 Participants
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.
|
|---|---|---|
|
Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance
|
0.9 score on a scale
Standard Deviation 4.9
|
-0.5 score on a scale
Standard Deviation 4.8
|
Adverse Events
Upneeq Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Upneeq Group
n=57 participants at risk
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.
|
Control Group
n=57 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Dry eye
|
5.3%
3/57 • Number of events 3 • 1 day: this study was a single time-instillation of a topical temporary medication
|
3.5%
2/57 • Number of events 2 • 1 day: this study was a single time-instillation of a topical temporary medication
|
|
General disorders
Headache
|
3.5%
2/57 • Number of events 2 • 1 day: this study was a single time-instillation of a topical temporary medication
|
1.8%
1/57 • Number of events 1 • 1 day: this study was a single time-instillation of a topical temporary medication
|
|
Eye disorders
Eyelid heaviness
|
5.3%
3/57 • Number of events 3 • 1 day: this study was a single time-instillation of a topical temporary medication
|
0.00%
0/57 • 1 day: this study was a single time-instillation of a topical temporary medication
|
|
Eye disorders
Light Sensitivity
|
1.8%
1/57 • Number of events 1 • 1 day: this study was a single time-instillation of a topical temporary medication
|
0.00%
0/57 • 1 day: this study was a single time-instillation of a topical temporary medication
|
|
Eye disorders
Temporary Blurry Vision
|
0.00%
0/57 • 1 day: this study was a single time-instillation of a topical temporary medication
|
1.8%
1/57 • Number of events 1 • 1 day: this study was a single time-instillation of a topical temporary medication
|
|
General disorders
Dizziness
|
0.00%
0/57 • 1 day: this study was a single time-instillation of a topical temporary medication
|
1.8%
1/57 • Number of events 1 • 1 day: this study was a single time-instillation of a topical temporary medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place