A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of NOV03 (Perfluorohexyloctane) on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 599
- 试验地点
- 29
- 主要终点
- Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
研究概览
简要总结
This trial will evaluate the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).
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 and Visit 1
- •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)
Placebo 4 times daily (QID)
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
时间窗: Assessed from Baseline to Day 57
Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Change From Baseline of Dryness Score at Day 57
时间窗: Assessed from Baseline to Day 57
Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
次要结局
未报告次要终点