The Effect of Lumify™ Eyedrops on Eyelid Position

Phase 4

Completed

• Conditions: Eyelid Droop
• Interventions: Other: Sterile balanced saline solution; Drug: Brimonidine tartrate ophthalmic solution 0.025%

• Registration Number: NCT03782701
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Study Start: 2019-06-18
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Results First Submitted: 2021-03-31
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-07
• Last Update Submitted: 2021-06-07
• Results First Posted: 2021-06-14
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Solution Eye Drop	Sterile balanced saline solution	Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
Lumify Eye Drop	Brimonidine tartrate ophthalmic solution 0.025%	Participants will be randomized to receive a single drop of Lumify to either the left or right eye.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States