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OpenTrials
Completed

NCT Number: NCT03782701

The Effect of Lumify™ Eyedrops on Eyelid Position

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

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Key information

Conditions

Eyelid Droop Blepharoptosis Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brimonidine tartrate ophthalmic solution 0.025%

Drug

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

Other names: Lumify

Sterile balanced saline solution

Other

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

Primary outcomes

  1. Palpebral Fissure Height

    Time frame: Baseline, 5, 15 and 30 minutes after application

    Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.

Secondary outcomes

  1. Intraocular Pressure

    Time frame: Baseline, 5, 15 and 30 minutes after application

    Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer

  2. Eye Redness

    Time frame: Baseline, 5, 15 and 30 minutes after application

    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).

  3. Eye Discomfort

    Time frame: Baseline, 5, 15 and 30 minutes after application

    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).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2018
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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