18 and older, any sex, with Eyelid Droop. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Palpebral Fissure HeightPrimary· Baseline, 5, 15 and 30 minutes after application
Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
Baseline
Group
Value
95% CI
Lumify Eye Drop
9.64
± 1.71
Saline Solution Eye Drop
9.66
± 1.62
5 minutes after application
Group
Value
95% CI
Lumify Eye Drop
9.92
± 1.33
Saline Solution Eye Drop
9.96
± 1.35
15 minutes after application
Group
Value
95% CI
Lumify Eye Drop
9.85
± 1.42
Saline Solution Eye Drop
9.96
± 1.40
30 minutes after application
Group
Value
95% CI
Lumify Eye Drop
9.86
± 1.32
Saline Solution Eye Drop
9.84
± 1.26
Intraocular PressureSecondary· Baseline, 5, 15 and 30 minutes after application
Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
Baseline
Group
Value
95% CI
Lumify Eye Drop
16.54
± 3.63
Saline Solution Eye Drop
16.70
± 3.42
30 minutes after applciation
Group
Value
95% CI
Lumify Eye Drop
15.54
± 3.30
Saline Solution Eye Drop
15.58
± 2.99
Eye RednessSecondary· 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).
Baseline - None
Group
Value
95% CI
Lumify Eye Drop
24
Saline Solution Eye Drop
25
Baseline - Mild
Group
Value
95% CI
Lumify Eye Drop
17
Saline Solution Eye Drop
16
Baseline - Moderate
Group
Value
95% CI
Lumify Eye Drop
2
Saline Solution Eye Drop
2
Baseline - Severe
Group
Value
95% CI
Lumify Eye Drop
0
Saline Solution Eye Drop
0
5 minutes after application - None
Group
Value
95% CI
Lumify Eye Drop
38
Saline Solution Eye Drop
6
5 minutes after application - Mild
Group
Value
95% CI
Lumify Eye Drop
4
Saline Solution Eye Drop
19
5 minutes after application - Moderate
Group
Value
95% CI
Lumify Eye Drop
1
Saline Solution Eye Drop
17
5 minutes after application - Severe
Group
Value
95% CI
Lumify Eye Drop
0
Saline Solution Eye Drop
1
Eye DiscomfortSecondary· 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).
Baseline - None
Group
Value
95% CI
Lumify Eye Drop
43
Saline Solution Eye Drop
43
Baseline - Mild
Group
Value
95% CI
Lumify Eye Drop
0
Saline Solution Eye Drop
0
Baseline - Moderate
Group
Value
95% CI
Lumify Eye Drop
0
Saline Solution Eye Drop
0
Baseline - Severe
Group
Value
95% CI
Lumify Eye Drop
0
Saline Solution Eye Drop
0
5 minutes after application - none
Group
Value
95% CI
Lumify Eye Drop
40
Saline Solution Eye Drop
38
5 minutes after application - mild
Group
Value
95% CI
Lumify Eye Drop
3
Saline Solution Eye Drop
4
5 minutes after application - moderate
Group
Value
95% CI
Lumify Eye Drop
0
Saline Solution Eye Drop
0
5 minutes after application - severe
Group
Value
95% CI
Lumify Eye Drop
0
Saline Solution Eye Drop
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 30 minutes.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 14 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03782701.