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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTulane University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Prisoners

Known allergy or sensitivities to brimonidine

No surgery within the past 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • sterile balanced saline solution

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Lumify ArmExperimental treatment 1 intervention
Group B: Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ocular redness

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)

Time frame
5 minutes after application of eye drop
2

Ocular redness

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)

Time frame
15 minutes after application of eye drop
3

Ocular redness

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)

Time frame
30 minutes after application of eye drop
4

Ocular redness

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)

Time frame
60 minutes after application of eye drop

Secondary outcomes

1

Palpebral fissure height

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

Time frame
60 minutes after application of eye drop
2

Eye discomfort

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

Time frame
60 minutes after application of eye drop

Other outcomes

Sponsors and contacts

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