The Effect of Lumify™ Eyedrops on Eyelid Position

Overview

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

Full Title of Study: “The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2020

Interventions

  • Drug: Brimonidine tartrate ophthalmic solution 0.025%
    • One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
  • Other: Sterile balanced saline solution
    • One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)

Arms, Groups and Cohorts

  • Active Comparator: Lumify Eye Drop
    • Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Intraocular Pressure
    • Time Frame: Baseline, 5, 15 and 30 minutes after application
    • Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
  • Eye Redness
    • Time Frame: 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).
  • Eye Discomfort
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Miami
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wendy Lee, Associate Professor of Ophthalmology and Dermatology – University of Miami
  • Overall Official(s)
    • Wendy W Lee, MD, MS, Principal Investigator, Bascom Palmer Eye Institute

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