A Phase 2, Multi-Center, Randomized, Double-Masked, Saline-Controlled Study to Evaluate the Effect of Perfluorohexyloctane (NOV03) at Two Different Dosing Regimens on Signs and Symptoms of Dry Eye Disease (DED)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novaliq GmbH
- 入组人数
- 336
- 试验地点
- 2
- 主要终点
- Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).
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
- Double (Participant, Investigator)
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)
Perfluorohexyloctance solution 4 times daily (QID)
干预措施: NOV03 (Drug)
NOV03 2 times daily (BID)
Perfluorohexyloctance solution 2 times daily (BID)
干预措施: NOV03 (Drug)
Placebo 4 times daily (QID)
Saline solution (0.9% sodium chloride solution) 4 times daily (QID)
干预措施: Placebo (Drug)
Placebo 2 times daily (BID)
Saline solution (0.9% sodium chloride solution) 2 times daily (BID)
干预措施: Placebo (Drug)
结局指标
主要结局
Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)
时间窗: baseline and 2 months
The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
次要结局
未报告次要终点