EUCTR2010-020932-20-GB进行中（未招募）1 期
A Double Masked, Placebo Controlled, Randomised, Parallel Group PhaseIIa Study to assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Provision of informed consent prior to any study specific procedures.
- •2.Non-diabetic males and females aged 18 to 80 years, inclusive.
- •3.Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open angle glaucoma (POAG), with IOP >20 mmHg and =36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit;
- •Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP =22 mmHg and =36 mmHg in the study eye while not on anti-glaucoma medication.
- •4.Must have a best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.6 logarithm of the minimum angle of resolution (logMAR [Snellen equivalent of 20/80]) or better in each eye.
- •5.Must have a <5 mmHg difference in mean IOP between eyes at 9AM at Baseline (Visit 3).
- •6.Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP.
- •7.Placebo treatment for duration of the study must not be considered detrimental to the patient.
- •8.Must be willing to discontinue soft contact lens wear from 7 days prior to Visit 3 until the completion of the final study visit or to discontinue hard contact lens wear from 1 month prior to Visit 3 until the completion of the final study visit.
- •9.Must be able to understand the consent form and comply with study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •Ocular Exclusion Criteria:
- •- Have uncontrolled intra-ocular hypertension (>36 mmHg).
- •- Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by >1 dB/yr average loss or vision threatening new defect). Patients with severe central field loss in either eye is defined as a sensitivity =10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
- •- Have narrow anterior chamber angles in either eye judged potentially occludable if pupillary dilatation were to occur, evidence or history of acute or chronic angle closure, or is at risk for angle closure as evidenced by anterior chamber angle less than grade 2 according to Schaffer classification, as measured by gonioscopy
- •General Exclusion Criteria:
- •- Women of child-bearing potential (WOCBP).
- •- Have uncontrolled systemic hypertension (BP >150/90)
- •- Are receiving systemic (including vaginal/rectal) or inhaled steroid treatment at the time of the screening visit (Visit 2).
- •- Have any screening laboratory abnormality that, in the investigator’s judgement, is considered to be clinically significant.
- •- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject’s ability to participate in the study.
- •- Had a change in dose or initiation of systemic therapies (including herbal medications, vitamins, and nutrient supplements [eg, fish oil, and zinc]) that can substantially affect IOP or the study outcome, such as (but not limited to) alpha adrenergic agents, beta-adrenergic blockers, calcium channel blockers, carbonic anhydrase inhibitors, angiotensin-converting enzyme inhibitors or other antihypertensive medications within 30 days prior to the screening visit (Visit 2), or anticipates a change in such therapy during the study.
研究者
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