Glaucoma Clinical Trial
Official 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%
Verified date | June 2023 |
Source | Tulane University |
Contact | Ze Zhang, MD |
Phone | 504-988-5831 |
zzhang9[@]tulane.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | June 1, 2035 |
Est. primary completion date | June 1, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Tulane University Medical Center | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Tulane University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Intraocular pressure | Measurement of intraocular pressure using handheld tonometer (TonoPen) | 60 minutes after application of eye drop | |
Secondary | Palpebral fissure height | Measurement of distance between inner margin of upper and lower eyelids from clinical photographs | 60 minutes after application of eye drop | |
Secondary | Eye discomfort | Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable) | 60 minutes after application of eye drop |
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