Droopy Eyelid, Glaucoma, Glaucoma; Drugs, Glaucoma, Open-Angle, Glaucoma, Primary Open Angle, Ptosis
Conditions
Brief summary
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.
Interventions
Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.
Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.
Sponsors
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular redness | 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) |
| Intraocular pressure | 60 minutes after application of eye drop | Measurement of intraocular pressure using handheld tonometer (TonoPen) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Palpebral fissure height | 60 minutes after application of eye drop | Measurement of distance between inner margin of upper and lower eyelids from clinical photographs |
| Eye discomfort | 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) |
Countries
United States
Contacts
Primary ContactZe Zhang, MD
Backup ContactWhitley Richardson
Outcome results
None listed