Back to resultsThe Effect of Lumify™ Eyedrops on Eyelid Position
Primary Purpose
Eyelid Droop
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brimonidine tartrate ophthalmic solution 0.025%
Sterile balanced saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Eyelid Droop
Eligibility Criteria
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
Sites / Locations
- Bascom Palmer Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lumify Eye Drop
Saline Solution Eye Drop
Arm Description
Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
Outcomes
Primary Outcome Measures
Palpebral Fissure Height
Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
Secondary Outcome Measures
Intraocular Pressure
Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
Eye Redness
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).
Eye Discomfort
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03782701
Brief Title
The Effect of Lumify™ Eyedrops on Eyelid Position
Official Title
The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the research is to see if Lumify™ has an effect on eyelid position.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Droop
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumify Eye Drop
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
Arm Title
Saline Solution Eye Drop
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate ophthalmic solution 0.025%
Other Intervention Name(s)
Lumify
Intervention Description
One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
Intervention Type
Other
Intervention Name(s)
Sterile balanced saline solution
Intervention Description
One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Intraocular Pressure
Description
Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
Time Frame
Baseline, 5, 15 and 30 minutes after application
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy W Lee, MD, MS
Organizational Affiliation
Bascom Palmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Lumify™ Eyedrops on Eyelid Position
We'll reach out to this number within 24 hrs