AR-12286 in Combination With Latanoprost
2014年4月18日 更新者：Aerie Pharmaceuticals
A Phase 2, Double-masked, Randomized, Active-controlled, Crossover Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 or Timolol Added to Patients With Elevated Intraocular Pressure Currently Using Latanoprost
This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
66
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Connecticut
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New Haven、Connecticut、美国、06510
- David Silverstone, M.D.
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Georgia
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Roswell、Georgia、美国、30076
- Coastal Research Associates, LLC
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Kansas
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Shawnee Mission、Kansas、美国、66204
- Heart of America Eye Care, P.A.
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Kentucky
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Louisville、Kentucky、美国、40217
- Taustine Eye Center
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Maryland
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Baltimore、Maryland、美国、21209
- Alan L Robin, M.D.
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Missouri
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St Louis、Missouri、美国、63090
- Comprehensive Eye Care
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New York
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Rochester、New York、美国、14618
- Rochester Ophthalmology Group
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Slingerlands、New York、美国、12159
- Glaucoma Consultants of the Capital Region
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North Carolina
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Charlotte、North Carolina、美国、28210
- Charlotte Eye Ear Nose and Throat
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Charlotte、North Carolina、美国、28204
- Thomas K. Mundorf, M.D.
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Oklahoma
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Tulsa、Oklahoma、美国、74104
- The Eye Institute
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Wills Eye Hospital
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South Dakota
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Rapid City、South Dakota、美国、57701
- Black Hills Regional Eye Institute
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Texas
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El Paso、Texas、美国、79902
- Cataract & Glaucoma Center
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Utah
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Salt Lake City、Utah、美国、84117
- Stacy R. Smith, M.D.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1 month at time of study entry (first qualification visit) in study eye(s).
- Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm Hg; Combination therapy patients: >= 16 mm Hg. Qualification Visit 2 (post latanoprost run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in study eye(s). (Note: combination therapy may include any combination of topical ocular hypotensive agents).
- Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
- Able and willing to give signed informed consent and follow study instructions
Exclusion Criteria:
In either eye:
- Previously randomized to treatment in a clinical study of AR-12286.
- Intraocular pressure > 36 mm Hg.
- History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy
- Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics, including history of conjunctival hyperemia with topical latanoprost of severity greater than 1 on a 0-3 scale.
- Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
- Contact lens wear within 30 minutes of instillation of study medication.
- PG monotherapy patients: Ocular hypotensive medication (other than prostaglandin) within 4 weeks of Visit 0 (Study entry, first qualification visit). Combination therapy patients: Ocular hypotensive medication (other than prostaglandin and current additional agent) within 4 weeks of Visit 0 (Study entry, first qualification visit).
- Conjunctival hyperemia of grade 2+ or greater at Visit 1.
- Any other ocular medication within 4 weeks of Visit 1 with the exception of lubricating drops for dry eye (which may be used throughout the study).
- Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that treatment with only latanoprost for two periods of up to 4 weeks is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss).
- Any abnormality preventing reliable applanation tonometry of either eye.
In study eye(s):
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
- Previous glaucoma intraocular surgery or laser procedures.
- Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- Central corneal thickness greater than 600 µ.
Systemic:
- Known bronchial asthma (history or current), severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or overt cardiac failure.
- Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
- Participation in any investigational study within the past 30 days.
- Changes of systemic medication that could have a substantial effect on IOP 4 weeks prior to screening, or anticipated during the study.
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：AR-12286
AR-12286 Ophthalmic Solution 0.5%
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q.d.
其他名称：
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有源比较器：Timolol
Timolol maleate ophthalmic solution 0.5%
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q.d.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraocular pressure
大体时间：28 days
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The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint.
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28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ocular safety
大体时间：28 days
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Safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries.
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28 days
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Systemic safety
大体时间：28 days
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Heart rate, and blood pressure.
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28 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年2月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2011年2月18日
首先提交符合 QC 标准的
2011年2月22日
首次发布 (估计)
2011年2月24日
研究记录更新
最后更新发布 (估计)
2014年5月8日
上次提交的符合 QC 标准的更新
2014年4月18日
最后验证
2014年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Latanoprost 0.005%的临床试验
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Inotek Pharmaceuticals Corporation完全的
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TearClear Corp主动，不招人
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Azienda Socio Sanitaria Territoriale degli Spedali...Aristotle University Of Thessaloniki完全的