Trial Outcomes & Findings for The Effect of Lumify™ Eyedrops on Eyelid Position (NCT NCT03782701)
NCT ID: NCT03782701
Last Updated: 2021-06-14
Results Overview
Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
Baseline, 5, 15 and 30 minutes after application
Results posted on
2021-06-14
Participant Flow
Unit of analysis: eye
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
43 86
|
|
Overall Study
Lumify
|
43 43
|
|
Overall Study
Saline Solution
|
43 43
|
|
Overall Study
COMPLETED
|
43 86
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=43 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=43 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=43 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=43 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=43 Participants
|
PRIMARY outcome
Timeframe: Baseline, 5, 15 and 30 minutes after applicationPopulation: 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.
Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
Outcome measures
| Measure |
Lumify Eye Drop
n=40 eye
Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
|
Saline Solution Eye Drop
n=40 eye
Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
|
|---|---|---|
|
Palpebral Fissure Height
Baseline
|
9.64 milimeter
Standard Deviation 1.71
|
9.66 milimeter
Standard Deviation 1.62
|
|
Palpebral Fissure Height
5 minutes after application
|
9.92 milimeter
Standard Deviation 1.33
|
9.96 milimeter
Standard Deviation 1.35
|
|
Palpebral Fissure Height
15 minutes after application
|
9.85 milimeter
Standard Deviation 1.42
|
9.96 milimeter
Standard Deviation 1.40
|
|
Palpebral Fissure Height
30 minutes after application
|
9.86 milimeter
Standard Deviation 1.32
|
9.84 milimeter
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline, 5, 15 and 30 minutes after applicationPopulation: 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.
Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
Outcome measures
| Measure |
Lumify Eye Drop
n=43 eye
Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
|
Saline Solution Eye Drop
n=43 eye
Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
|
|---|---|---|
|
Intraocular Pressure
Baseline
|
16.54 mmHg
Standard Deviation 3.63
|
16.70 mmHg
Standard Deviation 3.42
|
|
Intraocular Pressure
30 minutes after applciation
|
15.54 mmHg
Standard Deviation 3.30
|
15.58 mmHg
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Baseline, 5, 15 and 30 minutes after applicationPopulation: 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.
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).
Outcome measures
| Measure |
Lumify Eye Drop
n=43 Participants
Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
|
Saline Solution Eye Drop
n=43 Participants
Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
|
|---|---|---|
|
Eye Redness
5 minutes after application - Severe
|
0 Participants
|
1 Participants
|
|
Eye Redness
15 minutes after application - None
|
40 Participants
|
18 Participants
|
|
Eye Redness
30 minutes after application - None
|
41 Participants
|
26 Participants
|
|
Eye Redness
30 minutes after application - Mild
|
1 Participants
|
17 Participants
|
|
Eye Redness
30 minutes after application - Severe
|
0 Participants
|
0 Participants
|
|
Eye Redness
15 minutes after application - Severe
|
0 Participants
|
0 Participants
|
|
Eye Redness
Baseline - None
|
24 Participants
|
25 Participants
|
|
Eye Redness
Baseline - Mild
|
17 Participants
|
16 Participants
|
|
Eye Redness
Baseline - Moderate
|
2 Participants
|
2 Participants
|
|
Eye Redness
Baseline - Severe
|
0 Participants
|
0 Participants
|
|
Eye Redness
5 minutes after application - None
|
38 Participants
|
6 Participants
|
|
Eye Redness
5 minutes after application - Mild
|
4 Participants
|
19 Participants
|
|
Eye Redness
5 minutes after application - Moderate
|
1 Participants
|
17 Participants
|
|
Eye Redness
15 minutes after application - Mild
|
2 Participants
|
24 Participants
|
|
Eye Redness
15 minutes after application - Moderate
|
1 Participants
|
1 Participants
|
|
Eye Redness
30 minutes after application - Moderate
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 5, 15 and 30 minutes after applicationPopulation: 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.
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).
Outcome measures
| Measure |
Lumify Eye Drop
n=43 Participants
Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
|
Saline Solution Eye Drop
n=43 Participants
Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
|
|---|---|---|
|
Eye Discomfort
Baseline - None
|
43 Participants
|
43 Participants
|
|
Eye Discomfort
Baseline - Mild
|
0 Participants
|
0 Participants
|
|
Eye Discomfort
Baseline - Moderate
|
0 Participants
|
0 Participants
|
|
Eye Discomfort
Baseline - Severe
|
0 Participants
|
0 Participants
|
|
Eye Discomfort
5 minutes after application - none
|
40 Participants
|
38 Participants
|
|
Eye Discomfort
5 minutes after application - mild
|
3 Participants
|
4 Participants
|
|
Eye Discomfort
5 minutes after application - moderate
|
0 Participants
|
0 Participants
|
|
Eye Discomfort
5 minutes after application - severe
|
0 Participants
|
1 Participants
|
|
Eye Discomfort
15 minutes after application - severe
|
0 Participants
|
0 Participants
|
|
Eye Discomfort
15 minutes after application - none
|
41 Participants
|
40 Participants
|
|
Eye Discomfort
15 minutes after application - mild
|
1 Participants
|
2 Participants
|
|
Eye Discomfort
15 minutes after application - moderate
|
1 Participants
|
1 Participants
|
|
Eye Discomfort
30 minutes after application - none
|
39 Participants
|
40 Participants
|
|
Eye Discomfort
30 minutes after application - mild
|
4 Participants
|
3 Participants
|
|
Eye Discomfort
30 minutes after application - moderate
|
0 Participants
|
0 Participants
|
|
Eye Discomfort
30 minutes after application - severe
|
0 Participants
|
0 Participants
|
Adverse Events
Lumify Eye Drop
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Saline Solution Eye Drop
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lumify Eye Drop
n=43 participants at risk
Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
|
Saline Solution Eye Drop
n=43 participants at risk
Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
|
|---|---|---|
|
Eye disorders
Eye Pain
|
4.7%
2/43 • Number of events 2 • Up to 30 minutes
|
4.7%
2/43 • Number of events 2 • Up to 30 minutes
|
|
Eye disorders
Eye Itchiness
|
2.3%
1/43 • Number of events 1 • Up to 30 minutes
|
0.00%
0/43 • Up to 30 minutes
|
|
Eye disorders
Eye Dryness
|
7.0%
3/43 • Number of events 3 • Up to 30 minutes
|
0.00%
0/43 • Up to 30 minutes
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place