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The purpose of the research is to see if Lumify™ has an effect on eyelid position.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumify Eye Drop | Active Comparator | Participants will be randomized to receive a single drop of Lumify to either the left or right eye. |
|
| Saline Solution Eye Drop | Active Comparator | Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.025% | Drug | One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Palpebral Fissure Height | Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs. | Baseline, 5, 15 and 30 minutes after application |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer | Baseline, 5, 15 and 30 minutes after application |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy W Lee, MD, MS | Bascom Palmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Palpebral Fissure Height | Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs. | 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. | Posted | Mean | Standard Deviation | milimeter | Baseline, 5, 15 and 30 minutes after application | eye | eye |
|
Up to 30 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumify Eye Drop | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wendy Lee | Bascom Palmer Eye Institute | (305) 243-2020 | wlee@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2018 | May 10, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
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|
| Sterile balanced saline solution | Other | One time dosing of sterile balanced saline solution (1 drop applied to ocular surface) |
|
| Baseline, 5, 15 and 30 minutes after application |
| 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). | Baseline, 5, 15 and 30 minutes after application |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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. Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface) |
|
|
| Secondary | Intraocular Pressure | Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 5, 15 and 30 minutes after application | eye | eye |
|
|
|
| Secondary | 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). | 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. | Posted | Count of Participants | Participants | Baseline, 5, 15 and 30 minutes after application |
|
|
|
| Secondary | 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). | 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. | Posted | Count of Participants | Participants | Baseline, 5, 15 and 30 minutes after application |
|
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|
| 0 |
| 43 |
| 0 |
| 43 |
| 6 |
| 43 |
| EG001 | 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. Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface) | 0 | 43 | 0 | 43 | 2 | 43 |
| Eye Itchiness | Eye disorders | Systematic Assessment |
|
| Eye Dryness | Eye disorders | Systematic Assessment |
|
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| Baseline - Moderate |
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| Baseline - Severe |
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| 5 minutes after application - None |
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| 5 minutes after application - Mild |
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| 5 minutes after application - Moderate |
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| 5 minutes after application - Severe |
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| 15 minutes after application - None |
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| 15 minutes after application - Mild |
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| 15 minutes after application - Moderate |
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| 15 minutes after application - Severe |
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| 30 minutes after application - None |
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| 30 minutes after application - Mild |
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| 30 minutes after application - Moderate |
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| 30 minutes after application - Severe |
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| Baseline - Moderate |
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| Baseline - Severe |
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| 5 minutes after application - none |
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| 5 minutes after application - mild |
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| 5 minutes after application - moderate |
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| 5 minutes after application - severe |
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| 15 minutes after application - none |
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| 15 minutes after application - mild |
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| 15 minutes after application - moderate |
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| 15 minutes after application - severe |
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| 30 minutes after application - none |
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| 30 minutes after application - mild |
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| 30 minutes after application - moderate |
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| 30 minutes after application - severe |
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