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%
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ocular redness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lumify Arm
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.
干预措施: brimonidine tartrate ophthalmic solution 0.025% (Drug)
Control Arm
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.
干预措施: sterile balanced saline solution (Other)
结局指标
主要结局
Ocular redness
时间窗: 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)
Intraocular pressure
时间窗: 60 minutes after application of eye drop
Measurement of intraocular pressure using handheld tonometer (TonoPen)
次要结局
- Eye discomfort(60 minutes after application of eye drop)
- Palpebral fissure height(60 minutes after application of eye drop)