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The Effect of Lumify™ Eyedrops on Eyelid Position

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ClinicalTrials.gov Identifier: NCT03782701
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Wendy Lee, University of Miami

Brief Summary:
This research study designed to test if Lumify™ eyedrops temporarily raise the upper eyelid. Lumify™ is an FDA approved medication for reducing eye redness. A similar, but stronger product is also used to treat glaucoma. Whether or not it affects the position of the eyelids has not been studied, but we believe that it will raise the position of the upper eyelid, making the eye appear more open.

Condition or disease Intervention/treatment Phase
Eyelid Droop Drug: brimonidine tartrate ophthalmic solution 0.025% Other: sterile balanced saline solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Each patient will be randomized to receive medication in one eye and placebo in the other.
Masking: None (Open Label)
Masking Description: Data analysis will be conducted on clinical photographs. Analyzer will be blinded to which eye received intervention versus placebo.
Primary Purpose: Treatment
Official Title: The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Experimental
For each patient, each eye will be randomized to receive a single drop of either brimonidine tartrate ophthalmic solution 0.025% or a sterile balanced saline solution.
Drug: brimonidine tartrate ophthalmic solution 0.025%
One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
Other Name: Lumify

Sham Comparator: Control
For each patient, each eye will be randomized to receive a single drop of either brimonidine tartrate ophthalmic solution 0.025% or a sterile balanced saline solution.
Other: sterile balanced saline solution
One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)




Primary Outcome Measures :
  1. Palpebral fissure height [ Time Frame: 5 minutes after application ]
    Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs

  2. Palpebral fissure height [ Time Frame: 15 minutes after application ]
    Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs

  3. Palpebral fissure height [ Time Frame: 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 [ Time Frame: 30 minutes after application ]
    Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer

  2. Eye redness [ Time Frame: 5 minutes after application ]
    Scoring of ocular redness from clinical photographs on a 0 - 4 unit scale as compared to standardized reference photographs (0 = no redness, 4 = very red)

  3. Eye redness [ Time Frame: 15 minutes after application ]
    Scoring of ocular redness from clinical photographs on a 0 - 4 unit scale as compared to standardized reference photographs (0 = no redness, 4 = very red)

  4. Eye redness [ Time Frame: 30 minutes after application ]
    Scoring of ocular redness from clinical photographs on a 0 - 4 unit scale as compared to standardized reference photographs (0 = no redness, 4 = very red)

  5. Eye discomfort [ Time Frame: 5 minutes after application ]
    Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable)

  6. Eye discomfort [ Time Frame: 15 minutes after application ]
    Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable)

  7. Eye discomfort [ Time Frame: 30 minutes after application ]
    Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782701


Contacts
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Contact: Wendy W Lee, MD, MS 305-326-6434 WLee@med.miami.edu

Locations
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United States, Florida
Bascom Palmer Eye Institute Not yet recruiting
Miami, Florida, United States, 33136
Contact: Alexandra E Levitt, MD, MPH       alevitt@med.miami.edu   
Principal Investigator: Wendy W Lee, MD, MS         
Sponsors and Collaborators
Wendy Lee
Investigators
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Principal Investigator: Wendy W Lee, MD, MS Bascom Palmer Eye Institute

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Responsible Party: Wendy Lee, Associate Professor of Ophthalmology and Dermatology, University of Miami
ClinicalTrials.gov Identifier: NCT03782701     History of Changes
Other Study ID Numbers: 20180895
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Brimonidine Tartrate
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs