NCT01059955已完成1 期
Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study
John Kempen6 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. A secondary goal is to get preliminary information about whether the treatment is likely to be an effective treatment for scleritis. If the results are favorable, further trials evaluating the treatment may be pursued.
Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.
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
- •Male or female age at least 18 years
- •A diagnosis of active non-infectious, non-necrotizing anterior scleritis (nodular or diffuse is acceptable)
- •Not planning to undergo elective ocular surgery during the study
- •Provide written informed consent
- •Be able and willing to follow instructions, return for all study visits, and willing to comply with all study-related instructions
- •If female and of childbearing potential; submit a urine sample and have a negative pregnancy test at Visit 1; agree to use an acceptable method of contraception during the study. A woman is considered of childbearing potential unless she is surgically sterile (hysterectomy or tubal ligation) or is post-menopausal (has not had a menstrual cycle for >2 years or has laboratory evidence of a post-menopausal state). Acceptable methods of contraception include: spermicide with barrier, hormonal contraception, IUD, or surgical sterilization of partner. Complete abstinence throughout the study period also is acceptable.
排除标准
- •Contraindications to the use of the test articles
- •Known allergy or sensitivity to any medication used in this study, including the study medication or its components (e.g., corticosteroids)
- •For patients not taking systemic corticosteroids or immunosuppressants, any condition constituting conferring a likelihood that systemic corticosteroids or immunosuppressants would need to be started during the 56-day study period
- •For patients already taking systemic corticosteroids and/or immunosuppressants, any condition conferring a likelihood that systemic corticosteroid or immunosuppressant dosage would need to be changed during the 56-day study period
- •Intraocular pressure high enough that intraocular pressure-lowering medications are likely to be needed (≥25 mmHg or IOP>target pressure for patients with glaucoma); and/or more than two ocular anti-hypertensive medications (prior IOP-lowering surgery is acceptable; combinations of two agents such as Cosopt or Combigan are considered two medications)
- •Glaucoma sufficiently advanced that an intraocular pressure spike would potentially put the patient at substantial risk of vision loss, per the clinician-investigator's judgment.
- •Subject is planning to undergo elective surgery during the study period
- •Any active ocular infections (bacterial, viral, or fungal), active ocular inflammation other than scleritis (i.e., follicular conjunctivitis, iritis), or preauricular lymphadenopathy
- •History or diagnosis of ocular herpes or corneal lesion of suspected herpetic origin
- •Severe eyelid or ocular surface lesions impeding application of the iontophoresis applicator
- •Severe / serious ocular pathology or medical condition which may preclude study completion
- •Any condition conferring a likelihood that topical ophthalmic medications in use at baseline would need to be changed during the 56-day study period.
- •History of Stevens-Johnson Syndrome or mucous membrane pemphigoid
- •Unwilling to discontinue use of contact lenses for the duration of the study
- •Any open wounds / skin disease on the forehead where the iontophoresis return electrode will be applied
- •Pacemakers and/or any other electrical sensitive support system
- •Any significant illness or condition that could, in the investigator's or sub-investigator's opinion, be expected to interfere with the study parameters or study conduct; or put the subject at significant risk
- •Be currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
- •Participation in an investigational drug or device study within 30 days of entering the study
研究组 & 干预措施
Active treatment at day 0 and day 7
Experimental
Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and one at Day 7.
The three iontophoresis doses are:
- Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA
- Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA
- Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA
干预措施: Dexamethasone Phosphate Ophthalmic Solution (EGP-437) (Drug)
Active Treatment at Day 0, Sham Treatment at Day 7
Active Comparator
Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and a sham treatment Day 7.
The three iontophoresis doses are:
- Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA
- Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA
- Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA
干预措施: Dexamethasone phosphate ophthalmic solution (Drug)
结局指标
主要结局
Dose-limiting toxicity
时间窗: 56 days
次要结局
- Improvement on scleritis scale score(56 days)
研究者
John Kempen
Associate Professor of Ophthalmology and Epidemiology
University of Pennsylvania
研究点 (6)
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