NCT01468168已完成2 期
A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 183
- 主要终点
- Tear volume increase from baseline
研究概览
简要总结
To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.
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
- Triple (Participant, 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
- •Individuals considered for entry into the study will be of either sex and any race who have:
- •a confirmed diagnosis of dry eye,
- •are willing to use no ocular treatments during the study other than study medication,
- •have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
- •will not use contact lenses during the study,
- •Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
- •18 years of age or older,
- •able to understand and provide written informed consent
排除标准
- •Subjects with any of the following are not eligible to participate in the study:
- •Fluorescein corneal staining or conjunctival staining that is too severe
- •Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
- •Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
- •Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
- •Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
- •Ocular(including lid)disease/abnormality that may interfere with the study
- •Corneal transplant in either eye, at any time prior to enrollment in the study
- •Laser refractive surgery less than one year prior to Visit 1 (Day 1)
- •Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
- •Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
- •Known allergy or sensitivity to any of the study medication components
- •Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
- •A woman who is pregnant, nursing, or planning a pregnancy
- •Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)
研究组 & 干预措施
DE-101 Ophthalmic Suspension High Dose
Experimental
干预措施: DE-101 Ophthalmic Suspension (Drug)
DE-101 Ophthalmic Suspension Low Dose
Experimental
干预措施: DE-101 Ophthalmic Suspension (Drug)
DE-101 Ophthalmic Suspension Vehicle
Placebo Comparator
干预措施: DE-101 Ophthalmic Suspension Vehicle (Drug)
结局指标
主要结局
Tear volume increase from baseline
时间窗: baseline and 6 months
次要结局
未报告次要终点
研究者
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