The Effect of Lumify™ Eyedrops on Eyelid Position

NCT ID: NCT03782701

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2020-04-01

Brief Summary

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

Conditions

Eyelid Droop

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lumify Eye Drop

Participants will be randomized to receive a single drop of Lumify to either the left or right eye.

Group Type: ACTIVE_COMPARATOR

Brimonidine tartrate ophthalmic solution 0.025%

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Sterile balanced saline solution

Intervention Type: OTHER

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

Interventions

Brimonidine tartrate ophthalmic solution 0.025%

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

Intervention Type: DRUG

Sterile balanced saline solution

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

Intervention Type: OTHER

Other Intervention Names

Lumify

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Wendy Lee

Associate Professor of Ophthalmology and Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy W Lee, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Bascom Palmer Eye Institute

Locations

Bascom Palmer Eye Institute

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20180895

Identifier Type: -

Identifier Source: org_study_id