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NCT03782701

The Effect of Lumify™ Eyedrops on Eyelid Position

Completed Phase 4 Results posted Last updated 14 June 2021
What this trial tests

Phase 4 trial testing Brimonidine tartrate ophthalmic solution 0.025% in Eyelid Droop in 43 participants. Completed in 1 April 2020.

Timeline
18 June 2019
Primary endpoint
1 April 2020
1 April 2020

Quick facts

Lead sponsorUniversity of Miami
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment43
Start date18 June 2019
Primary completion1 April 2020
Estimated completion1 April 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Miami

Who can join

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 Height Primary · Baseline, 5, 15 and 30 minutes after application

Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.

Baseline
GroupValue95% CI
Lumify Eye Drop9.64± 1.71
Saline Solution Eye Drop9.66± 1.62
5 minutes after application
GroupValue95% CI
Lumify Eye Drop9.92± 1.33
Saline Solution Eye Drop9.96± 1.35
15 minutes after application
GroupValue95% CI
Lumify Eye Drop9.85± 1.42
Saline Solution Eye Drop9.96± 1.40
30 minutes after application
GroupValue95% CI
Lumify Eye Drop9.86± 1.32
Saline Solution Eye Drop9.84± 1.26
Intraocular Pressure Secondary · Baseline, 5, 15 and 30 minutes after application

Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer

Baseline
GroupValue95% CI
Lumify Eye Drop16.54± 3.63
Saline Solution Eye Drop16.70± 3.42
30 minutes after applciation
GroupValue95% CI
Lumify Eye Drop15.54± 3.30
Saline Solution Eye Drop15.58± 2.99
Eye Redness Secondary · 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
GroupValue95% CI
Lumify Eye Drop24
Saline Solution Eye Drop25
Baseline - Mild
GroupValue95% CI
Lumify Eye Drop17
Saline Solution Eye Drop16
Baseline - Moderate
GroupValue95% CI
Lumify Eye Drop2
Saline Solution Eye Drop2
Baseline - Severe
GroupValue95% CI
Lumify Eye Drop0
Saline Solution Eye Drop0
5 minutes after application - None
GroupValue95% CI
Lumify Eye Drop38
Saline Solution Eye Drop6
5 minutes after application - Mild
GroupValue95% CI
Lumify Eye Drop4
Saline Solution Eye Drop19
5 minutes after application - Moderate
GroupValue95% CI
Lumify Eye Drop1
Saline Solution Eye Drop17
5 minutes after application - Severe
GroupValue95% CI
Lumify Eye Drop0
Saline Solution Eye Drop1
Eye Discomfort Secondary · 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
GroupValue95% CI
Lumify Eye Drop43
Saline Solution Eye Drop43
Baseline - Mild
GroupValue95% CI
Lumify Eye Drop0
Saline Solution Eye Drop0
Baseline - Moderate
GroupValue95% CI
Lumify Eye Drop0
Saline Solution Eye Drop0
Baseline - Severe
GroupValue95% CI
Lumify Eye Drop0
Saline Solution Eye Drop0
5 minutes after application - none
GroupValue95% CI
Lumify Eye Drop40
Saline Solution Eye Drop38
5 minutes after application - mild
GroupValue95% CI
Lumify Eye Drop3
Saline Solution Eye Drop4
5 minutes after application - moderate
GroupValue95% CI
Lumify Eye Drop0
Saline Solution Eye Drop0
5 minutes after application - severe
GroupValue95% CI
Lumify Eye Drop0
Saline Solution Eye Drop1

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.

Lumify Eye Drop
Serious: 0/43 (0%)
Deaths: 0/43
Saline Solution Eye Drop
Serious: 0/43 (0%)
Deaths: 0/43
Other adverse events (3 terms — click to expand)

ReactionSystemLumify Eye DropSaline Solution Eye Drop
Eye DrynessEye disorders
Eye PainEye disorders
Eye ItchinessEye disorders

Data from ClinicalTrials.gov NCT03782701 adverse events section.

Sponsor's own description

The purpose of the research is to see if Lumify™ has an effect on eyelid position.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Brimonidine tartrate ophthalmic solution 0.025%

Trials testing the same drug.

Other University of Miami trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing