A Phase 3, Multi-Center, Open-Label, Single-Arm Extension Clinical Trial to Assess the Extended Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 28
- 主要终点
- Number of Participants With Ocular and Non-ocular Adverse Events
研究概览
简要总结
The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction).
Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
详细描述
The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction).
Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed ICF (Informed Consent Form)
- •Subject-reported history of Drye Eye Disease (DED) in both eyes
- •Ability and willingness to follow instructions, including participation in all study assessments and visits
排除标准
- •Women who are pregnant, nursing or planning pregnancy
- •Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
- •Clinically significant slit-lamp findings or abnormal lid anatomy at screening
- •Ocular/peri-ocular malignancy
- •History of herpetic keratitis
- •Active ocular allergies or ocular allergies that are expected to be active during the study
- •Ongoing ocular or systemic infection
- •Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
- •Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
- •Presence of uncontrolled systemic diseases
- •Presence of known allergy and/or sensitivity to the study drug or saline components
- •Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
研究组 & 干预措施
NOV03 4 times daily (QID)
100% Perfluorohexyloctance solution 4 times daily (QID)
干预措施: NOV03 (Drug)
结局指标
主要结局
Number of Participants With Ocular and Non-ocular Adverse Events
时间窗: 12 months
次要结局
未报告次要终点