The Effect of Lumify™ Eyedrops on Eyelid Position

NCT03782701 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20180895
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eyelid Droop

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intraocular Pressure

  Baseline, 5, 15 and 30 minutes after application

• Eye Redness

  Baseline, 5, 15 and 30 minutes after application

• Eye Discomfort

  Baseline, 5, 15 and 30 minutes after application

Study Arms (2)

Lumify Eye Drop

ACTIVE COMPARATOR

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%

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.

Other: Sterile balanced saline solution

Interventions

Brimonidine tartrate ophthalmic solution 0.025% DRUG

One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)

Also known as: Lumify

Lumify Eye Drop

Sterile balanced saline solution OTHER

One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)

Saline Solution Eye Drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Blepharoptosis

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Wendy Lee
• Organization: Bascom Palmer Eye Institute

wlee@med.miami.edu

(305) 243-2020

Study Officials

• Wendy W Lee, MD, MS

  Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology and Dermatology

Model Details: The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 20, 2018
• Study Start: June 18, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)