The Effect of Lumify™ Eyedrops on Eyelid Position

University of Miami

Status and phase: Completed; Phase 4

Conditions: Eyelid Droop

Treatments: Other: Sterile balanced saline solution; Drug: Brimonidine tartrate ophthalmic solution 0.025%

Study type: Interventional

Funder types: Other

Identifiers

NCT03782701

20180895

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Lumify Eye Drop

Active Comparator group

Description:

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

Treatment:

Drug: Brimonidine tartrate ophthalmic solution 0.025%

Saline Solution Eye Drop

Active Comparator group

Description:

Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.

Treatment:

Other: Sterile balanced saline solution