Phase 4 N=43 Randomized Treatment

The Effect of Lumify™ Eyedrops on Eyelid Position

Eyelid Droop

Bottom Line

View on ClinicalTrials.gov: NCT03782701 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Palpebral Fissure Height — 9.64; 9.66; 9.92; 9.96 milimeter

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Brimonidine tartrate ophthalmic solution 0.025% (Drug); Sterile balanced saline solution (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Palpebral Fissure Height	9.64; 9.66; 9.92; 9.96; 9.85; 9.96	—
SECONDARY Intraocular Pressure	16.54; 16.70; 15.54; 15.58	—
SECONDARY Eye Redness	24; 25; 17; 16; 2; 2	—
SECONDARY Eye Discomfort	43; 43; 0; 0; 0; 0	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03782701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.