NCT07209410招募中4 期
Impact of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年11月1日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Effron Grading scale of ocular redness
研究概览
简要总结
To evaluate the effect of brimonidine tartrate 0.025% on conjunctival hyperemia in patients treated with netarsudil 0.02%/latanoprost 0.005% mono-therapy for intraocular pressure lowering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Adult patients 18-65 years old diagnosed with open-angle glaucoma or ocular hypertension.
- •2. Currently on netarsudil 0.02%/latanoprost 0.005% monotherapy for a minimum of 2-6 weeks.
- •3. Able to move from current topical glaucoma treatment to netarsudil 0.02%/latanoprost 0.005% for a minimum of 4 weeks or longer based on FDA recommended washout per drug classification prior to Visit
- •4. Experience conjunctival redness as graded on the Efron scale of at least grade 2 after minimum of 4 weeks on netarsudil 0.02%/latanoprost 0.005% mono-therapy or longer based on recommended washout per drug classification
- •Have a best corrected Visual Acuity by Snellen chart of 20/30 or better in study eye.
- •5. Are willing and able to self-administer or have an able person available to assist with administration of study drug.
- •Willing and able to comply with study procedures and attend follow-up visits.
排除标准
- •Allergy or hypersensitivity to brimonidine or other components of brimonidine tartrate 0.025% or netarsudil 0.02%/latanoprost 0.005%.
- •Use of any other topical ocular medications.
- •Active ocular infection, inflammation unrelated to glaucoma therapy, uveitis, iritis or congenital aphakia.
- •Have pterygium/pinguecula, chemosis, episcleritis, scleritis (or any condition that may affect hyperemia grading) in the opinion of the investigator
- •Have moderate or severe dry eyes.
- •Pregnant, plan to become pregnant or breastfeeding.
- •Concurrent or past use in the last 90 days of vasoconstrictive ocular drops other than brimondine 0.025%
- •Have undergone previous incision IOP lowering surgeries.
- •Have undergone previous laser surgery for glaucoma (selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)), or microinvasive glaucoma surgery (MIGS) with 6 months of screening.
- •Have had intraocular or per-ocular surgery within the past 3 months.
- •Advanced glaucoma or c/d ratio greater than 0.
- •Are non-responsive to topical treatment with netarsudil 0.02%/latanoprost 0.005%.
- •In the judgement of the investigator, have previous or currently active clinically significant systemic or ocular disease in either eye that could affect study outcomes.
研究组 & 干预措施
Brimonidine Tartrate
Experimental
Patients experiencing hyperemia greater than grade 2 on Efron scale will receive brimonidine tartrate (Lumify). Photo documentation of hyperemia and patient satisfaction questionnaires will be administered.
干预措施: Brimonidine Tartrate Ophthalmic 0.025% (Drug)
结局指标
主要结局
Effron Grading scale of ocular redness
时间窗: 2 weeks
Measuring Ocular Hyperemia and injection. This is measured on Scale 0-4 0- Normal 1. Trace 2. Mild 3. Moderate 4. Severe
次要结局
未报告次要终点
研究者
Crystal Remington
Optometrist
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
研究点 (1)
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