The Effect of Lumify™ Eyedrops on Eyelid Position

The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height

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

Study Overview

• Status: Completed
• Conditions: Eyelid Droop
• Intervention / Treatment: Drug: Brimonidine tartrate ophthalmic solution 0.025%; Other: Sterile balanced saline solution

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Wendy W Lee, MD, MS, Bascom Palmer Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharoptosis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 20180895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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