24-hour Effect Of Rocklatan Compared With Latanoprost In Open Angle Glaucoma And Ocular Hypertension Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in mean Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT).
详细描述
This will be a double-masked, paired-contralateral, descriptive study to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT). Study medication will be administered for 14 consecutive days, although the total time of subject participation in the study (including washout from prior treatment, if necessary) may be up to 10 weeks.
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
- Double (Participant, Investigator)
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
- •Diagnosis of OHT or mild-to-moderate OAG in both eyes (OAG in one eye and OHT in the fellow eye is acceptable) based on VF, OCT and dilated fundus examination within one year of the screening visit.
- •Both eyes must qualify for the study with an IOP of ≥18 mmHg but ≤34 mmHg on history or at the screening visit
- •Be able and willing to provide signed informed consent and follow study instructions
- •Ability to cooperate with the examinations required for the study and be able to attend all study visits
- •If a contact lens wearer, willing to remove contact lenses at least 24 hours prior to each of the study visits.
- •Best-corrected visual acuity (BCVA) using ETDRS chart of +0.4 logMAR units (Snellen equivalent ~ 20/50) or better in each eye
排除标准
- •Subjects with narrow angles (3 quadrants with Grade 2 or less according to Shaffer Scale), angle closure or a history of angle closure, or peripheral iridotomy in either eye
- •Severe glaucomatous damage
- •Difference in IOP between eyes > 4 mmHg (unmedicated) at any baseline time point
- •Use of more than two ocular hypotensive medications within 30 days of screening
- •Chronic or recurrent inflammatory eye diseases in either eye
- •Ocular infection or ocular inflammation in the past 3 months in either eye
- •Ocular trauma other than corneal abrasion within the past 6 months in either eye
- •Clinically significant retinal disease (e.g., severe diabetic retinopathy, exudative or severe non-exudative macular degeneration, macular edema, retinal vein or artery occlusion) in either eye
- •Cornea pathologic changes preventing reliable measurement (e.g., scarring, opacity, edema, keratoconus) in either eye
- •Myopia greater than -6.00D, or hyperopia greater than +2.00D in either eye
- •Central corneal thickness less than 480 μm or greater than 620 μm in either eye
- •Previous intraocular surgery other than routine uncomplicated cataract surgery in either eye
- •Previous glaucoma intraocular surgery or glaucoma laser procedures (except SLT performed more than 6 months ago) in either eye
- •Unilateral intraocular surgery or glaucoma laser procedures
- •Previous corneal refractive surgery in either eye (eg, radial keratotomy, PRK, LASIK, corneal cross-linking, etc.)
- •Severe dry eye in either eye
- •Use of ocular medications in either eye within 30 days of screening, with the exception of IOP-lowering medications (which must be washed out according to the provided schedule), and lubricating drops for dry eye (which may be used throughout the study)
- •Known hypersensitivity to any component of the formulation (eg, benzalkonium chloride, etc.), or to topical anesthetic
- •Clinically significant systemic diseases which might interfere with the study
- •Participation in any interventional study within 30 days prior to screening visit
- •Changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study including, β-adrenergic antagonists, α-adrenergic agonists and antagonists, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers
- •Recent change in medications that are known to affect IOP within 30 days prior to the screening visit and during the study including: systemic/inhaled steroids, calcium channel blockers, diuretics, and vasodilators
- •Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative pregnancy test result at the screening examination and must not intend to become pregnant during the study
- •Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
研究组 & 干预措施
latanoprost arm
干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)
netarsudil-latanoprost arm
干预措施: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution (Drug)
结局指标
主要结局
Change in mean Intraocular Pressure (IOP)
时间窗: Change in mean IOP after 2 weeks of treatment with Latanoprost compared to baseline
Change in mean IOP from baseline at each time point for Latanoprost
Change in mean IOP
时间窗: Change in mean IOP from baseline after 2 weeks of treatment with latanoprost minus change in mean IOP from baseline after 2 weeks of treatment with Rocklatan
Change in mean IOP from Latanoprost at each time point for Rocklatan
Change in mean IOP
时间窗: Change in mean IOP after 2 weeks of treatment with Rocklatan compared to baseline
Change in mean IOP from baseline at each time point for Rocklatan
次要结局
- Change in mean nocturnal IOP(Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Rocklatan compared to baseline)
- Change in mean diurnal IOP(Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Rocklatan compared to baseline)
- Change in mean nocturnal IOP(Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Latanoprost compared to baseline)
- Change in mean diurnal IOP(Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Latanoprost compared to baseline)
研究者
Arthur J. Sit, M.D.
Principal Investigator
Mayo Clinic