Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate to Severe Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale
研究概览
简要总结
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥18 and <75 years of age
- •Presence of moderate to severe dry eye disease (DED) in at least one eye
排除标准
- •Presently using prescription eyedrops, except those used for dry eye disease, which must be discontinued 4 weeks prior
- •Use of over-the-counter (OTC) eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- •History or evidence of ocular infection within the previous 30 days
- •Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
- •Allergic conjunctivitis requiring treatment within 30 days
- •Unable to discontinue contact lens wear for 2 weeks prior and for the duration of the study
研究组 & 干预措施
Vehicle
Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks)
干预措施: Vehicle (Drug)
INV-102
INV-102 0.7% ophthalmic solution administered for 4 weeks (twice daily [BID] for 2 weeks, then once daily [QD] for an additional 2 weeks)
干预措施: INV-102 (Drug)
结局指标
主要结局
Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale
时间窗: Baseline to Day 29
Corneal fluorescein staining assessment will be performed using the NEI grading system to score each of 5 corneal zones (central, superior, lateral, medial, inferior) on a 0 to 3 scale (with a total score of 0 to 15). Higher scores indicate more corneal damage.
次要结局
- Percentage of eyes with complete clearing of central corneal fluorescein staining(Baseline to Day 29)