The Effect of Lumify™ Eyedrops on Eyelid Position

Eyelid Droop Clinical Trial

Official title:

The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782701
• Other study ID #: 20180895
• Status: Completed
• Phase: Phase 4
• Start date: June 18, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: June 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis
• Eyelid Droop

Intervention

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

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

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraocular Pressure	Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer	Baseline, 5, 15 and 30 minutes after application
Secondary	Eye Redness	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).	Baseline, 5, 15 and 30 minutes after application
Secondary	Eye Discomfort	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).	Baseline, 5, 15 and 30 minutes after application