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NCT Number: NCT04007276

The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients

Glaucoma represents a group of conditions that cause damage to the optic nerve and can lead to irreversible vision loss. Current treatments are aimed at lowering intraocular pressure while minimizing medication side effects. Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) is an FDA-approved medication for alleviating eye redness, a common side effect of glaucoma medications. The purpose of this study is to evaluate the effect of Lumify™ on eye redness, intraocular pressure, and eyelid position in patients with glaucoma who are already using the Brimonidine 0.1%, 0.15% or 0.2% eye drops.

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Key information

Conditions

Glaucoma Blepharoptosis Droopy Eyelid Eye Diseases Eyelid Diseases Glaucoma, Open-Angle Glaucoma, Primary Open Angle Glaucoma; Drugs Ocular Hypertension Ptosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location contact

Ze Zhang, MD

CONTACT

[email protected]

504-988-5831

Ze Zhang, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Diagnosis of primary open angle glaucoma
  • Willing and able to give informed consent
  • Current and greater than 6 weeks of brimonidine 0.2%, 0.15% or 0.1% use

Exclusion criteria

  • Pregnancy
  • Prisoners
  • Known allergy or sensitivities to brimonidine
  • No surgery within the past 6 months
  • No history of lid surgery or botox
  • Any other significant ophthalmologic disorder or condition with relevant effect on ocular redness, IOP, or eyelid position as evaluated by principal investigator
  • Inability to sit comfortably for 30 minutes
  • Prior use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines, or phenylephrine dilating drops within 1 week of study

Treatment and study plan

Brimonidine tartrate ophthalmic solution 0.025%

Drug

Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.

Other names: Lumify™

Sterile balanced saline solution

Other

Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.

Primary outcomes

  1. Ocular redness

    Time frame: 5 minutes after application of eye drop

    Scoring of ocular redness on clinical photographs using the the Investigator Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness)

  2. Ocular redness

    Time frame: 15 minutes after application of eye drop

    Scoring of ocular redness on clinical photographs using the the Investigator Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness)

  3. Ocular redness

    Time frame: 30 minutes after application of eye drop

    Scoring of ocular redness on clinical photographs using the the Investigator Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness)

  4. Ocular redness

    Time frame: 60 minutes after application of eye drop

    Scoring of ocular redness on clinical photographs using the the Investigator Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness)

  5. Intraocular pressure

    Time frame: 60 minutes after application of eye drop

    Measurement of intraocular pressure using handheld tonometer (TonoPen)

Secondary outcomes

  1. Palpebral fissure height

    Time frame: 60 minutes after application of eye drop

    Measurement of distance between inner margin of upper and lower eyelids from clinical photographs

  2. Eye discomfort

    Time frame: 60 minutes after application of eye drop

    Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable)

Study contacts

Contact information is provided by the study sponsor or research team.

Whitley Richardson

CONTACT

[email protected]

504-988-2261

Ze Zhang, MD

CONTACT

[email protected]

504-988-5831

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients Using Brimonidine 0.2%, 0.15%, or 0.1%

Important dates

Study start
2026
Primary completion
2031
Study completion
2036
First posted
Jul 5, 2019
Registry last updated
Oct 1, 2025

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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