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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumify Arm | Experimental | In each subject, each eye will be randomized to receive a single drop of either Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) or a sterile balanced saline solution. |
|
| Control Arm | Sham Comparator | In each subject, each eye will be randomized to receive a single drop of either Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) or a sterile balanced saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 5 minutes after application of eye drop |
| 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) | 15 minutes after application of eye drop |
| 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) | 30 minutes after application of eye drop |
| 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) | 60 minutes after application of eye drop |
| Intraocular pressure | Measurement of intraocular pressure using handheld tonometer (TonoPen) | 60 minutes after application of eye drop |
| Measure | Description | Time Frame |
|---|---|---|
| Palpebral fissure height | Measurement of distance between inner margin of upper and lower eyelids from clinical photographs | 60 minutes after application of eye drop |
| Eye discomfort | Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ze Zhang, MD | Contact | 504-988-5831 | zzhang9@tulane.edu | |
| Whitley Richardson | Contact | 504-988-2261 | wrichardson@tulane.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ze Zhang, MD | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | United States |
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Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.
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|
| sterile balanced saline solution | Other | Single dose of sterile balanced saline solution applied as an eye drop to the eye surface. |
|
| 60 minutes after application of eye drop |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D001763 | Blepharoptosis |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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