The Effect of Lumify™ Eyedrops on Eyelid Position

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT03782701
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.5
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Eyelid Droop	Drug: Brimonidine tartrate ophthalmic solution 0.025%; Other: Sterile balanced saline solution	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height
• Actual Study Start Date: Jun 18, 2019
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lumify Eye Drop Participants will be randomized to receive a single drop of Lumify to either the left or right eye.	Drug: Brimonidine tartrate ophthalmic solution 0.025%; One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface); Other Names: Lumify
Active Comparator: Saline Solution Eye Drop Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.	Other: Sterile balanced saline solution; One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)

Outcome Measures

Primary Outcome Measures

1. Palpebral Fissure Height [Baseline, 5, 15 and 30 minutes after application]

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

Secondary Outcome Measures

1. Intraocular Pressure [Baseline, 5, 15 and 30 minutes after application]

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

2. Eye Redness [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).

3. Eye Discomfort [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

• Prisoners

• Pregnant women.

• Known contradictions or sensitivities to study medication (brimonidine)

• 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)

• Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 < 1mm)

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bascom Palmer Eye Institute	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Wendy W Lee, MD, MS, Bascom Palmer Eye Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 27, 2018

More Information

Publications

None provided.

• Responsible Party: Wendy Lee, Associate Professor of Ophthalmology and Dermatology, University of Miami
• ClinicalTrials.gov Identifier: NCT03782701
• Other Study ID Numbers: 20180895
• First Posted: Dec 20, 2018
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Blepharoptosis; Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	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.
Period Title: Overall Study
STARTED	43
Lumify	43
Saline Solution	43
COMPLETED	43
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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 Participants	43
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	40 93%
>=65 years	3 7%
Sex: Female, Male (Count of Participants)
Female	24 55.8%
Male	19 44.2%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Palpebral Fissure Height
Description	Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
Time Frame	Baseline, 5, 15 and 30 minutes after application

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lumify Eye Drop	Saline Solution Eye Drop
Arm/Group Description	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)	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)
Measure Participants	40	40
Measure eye	40	40
Baseline	9.64 (1.71)	9.66 (1.62)
5 minutes after application	9.92 (1.33)	9.96 (1.35)
15 minutes after application	9.85 (1.42)	9.96 (1.40)
30 minutes after application	9.86 (1.32)	9.84 (1.26)

2. Secondary Outcome

Title	Intraocular Pressure
Description	Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
Time Frame	Baseline, 5, 15 and 30 minutes after application

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lumify Eye Drop	Saline Solution Eye Drop
Arm/Group Description	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)	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)
Measure Participants	43	43
Measure eye	43	43
Baseline	16.54 (3.63)	16.70 (3.42)
30 minutes after applciation	15.54 (3.30)	15.58 (2.99)

3. Secondary Outcome

Title	Eye Redness
Description	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).
Time Frame	Baseline, 5, 15 and 30 minutes after application

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lumify Eye Drop	Saline Solution Eye Drop
Arm/Group Description	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)	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)
Measure Participants	43	43
Baseline - None	24 55.8%	25 NaN
Baseline - Mild	17 39.5%	16 NaN
Baseline - Moderate	2 4.7%	2 NaN
Baseline - Severe	0 0%	0 NaN
5 minutes after application - None	38 88.4%	6 NaN
5 minutes after application - Mild	4 9.3%	19 NaN
5 minutes after application - Moderate	1 2.3%	17 NaN
5 minutes after application - Severe	0 0%	1 NaN
15 minutes after application - None	40 93%	18 NaN
15 minutes after application - Mild	2 4.7%	24 NaN
15 minutes after application - Moderate	1 2.3%	1 NaN
15 minutes after application - Severe	0 0%	0 NaN
30 minutes after application - None	41 95.3%	26 NaN
30 minutes after application - Mild	1 2.3%	17 NaN
30 minutes after application - Moderate	1 2.3%	0 NaN
30 minutes after application - Severe	0 0%	0 NaN

4. Secondary Outcome

Title	Eye Discomfort
Description	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).
Time Frame	Baseline, 5, 15 and 30 minutes after application

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lumify Eye Drop	Saline Solution Eye Drop
Arm/Group Description	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)	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)
Measure Participants	43	43
Baseline - None	43 100%	43 NaN
Baseline - Mild	0 0%	0 NaN
Baseline - Moderate	0 0%	0 NaN
Baseline - Severe	0 0%	0 NaN
5 minutes after application - none	40 93%	38 NaN
5 minutes after application - mild	3 7%	4 NaN
5 minutes after application - moderate	0 0%	0 NaN
5 minutes after application - severe	0 0%	1 NaN
15 minutes after application - none	41 95.3%	40 NaN
15 minutes after application - mild	1 2.3%	2 NaN
15 minutes after application - moderate	1 2.3%	1 NaN
15 minutes after application - severe	0 0%	0 NaN
30 minutes after application - none	39 90.7%	40 NaN
30 minutes after application - mild	4 9.3%	3 NaN
30 minutes after application - moderate	0 0%	0 NaN
30 minutes after application - severe	0 0%	0 NaN

Adverse Events

Time Frame	Up to 30 minutes
Arm/Group Title	Lumify Eye Drop		Saline Solution Eye Drop
Arm/Group Description	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)		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)
All Cause Mortality
	Lumify Eye Drop		Saline Solution Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/43 (0%)
Serious Adverse Events
	Lumify Eye Drop		Saline Solution Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	Lumify Eye Drop		Saline Solution Eye Drop
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/43 (14%)		2/43 (4.7%)
Eye disorders
Eye Pain	2/43 (4.7%)	2	2/43 (4.7%)	2
Eye Itchiness	1/43 (2.3%)	1	0/43 (0%)	0
Eye Dryness	3/43 (7%)	3	0/43 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.