NCT01960010已完成3 期
A Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 Ophthalmic Solution in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model for the Treatment of Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Corneal Fluorescein Staining
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.
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
- •Be at least 18 years of age
- •Provided written informed consent
- •Have a reported history of dry eye
- •Have a history of use or desire to use eye drops for dry eye
排除标准
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have been diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months
- •Have any planned ocular and/or lid surgeries over the study period
- •Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1
- •Have an uncontrolled systemic disease
- •Be a woman who is pregnant, nursing or planning a pregnancy
- •Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study
- •Have a known allergy and/or sensitivity to the test article or its components
- •Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1
- •Be unable or unwilling to follow instructions, including participation in all study assessments and visits
研究组 & 干预措施
Vehicle
Placebo Comparator
Vehicle
干预措施: Vehicle (Drug)
1% MIM-D3
Active Comparator
1% MIM-D3 Ophthalmic Solution
干预措施: MIM-D3 Ophthalmic Solution (Drug)
结局指标
主要结局
Corneal Fluorescein Staining
时间窗: Day 29
Ocular Dryness
时间窗: 28 Days
Patient-derived, daily dryness symptoms for the 28 day time period will be be averaged to obtain a dryness score for the entire 28-day period. Average dryness scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests.
次要结局
- Total Ocular Fluorescein Staining(Day 29)
- Ocular Discomfort(28 Days)
研究者
研究点 (1)
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