Phase 2b, Proof-of-Concept, Single-center, Double-Masked, Randomized Study Comparing the Safety, Tolerability, and Efficacy of Three Different Ophthalmic Eyelid Wipe Dosing Techniques Using IVW-1001 in Subjects With Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tear production
研究概览
简要总结
Double-masked two period controlled trial of three eyelid wipe dosing techniques
详细描述
This is a randomized, single center, single -masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipe dosing techniques in subjects with DED. Treatments will be IVW 1001 Ophthalmic Eyelid Wipe 0.2% (low dose) and 0.4% (high dose). Subjects will participate in a 50-day, double -masked three dosing technique comparisons period using IVW-1001 Ophthalmic Eyelid Wipe 0.2% followed by a 14-day between period washout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All site personnel will be aware of the assigned IVW-1001 Ophthalmic Eyelid Wipe 0.2% concentration. However, subjects will be randomized to the sequence of the assigned dosing technique procedures which will be provided to individual subjects by the unmasked dosing technique coordinator only
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported diagnosis of DED in one or both eyes
- •BCVA +0.70 logarithm of minimum angle of refraction (Snellen equivalent 20/100) or better in each eye at the Screening Visit
- •For women of childbearing potential, confirmed negative pregnancy test at the Screening Visit, not nursing a child, and willing to comply with one of the acceptable methods of birth control described in the protocol
- •History (by subject recollection) of artificial tear use within 30 days prior to the Screening Visit
- •Unanesthetized Schirmer's test score 5-19 mm inclusive in at least 1 eye (same eye) at the Screening Visit and the Baseline Visit
排除标准
- •Corneal fluorescein staining score of 4 in either eye in any zone using the National Eye Institute grading system at either the Screening Visit or the Baseline Visit
- •IOP ≥23 mmHg in either eye at either the Screening Visit or the Baseline Visit
- •History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
研究组 & 干预措施
IVW-1001 Ophthalmic Wipe - Method 1
With eyes completely closed, the subject should wipe upper eyelid in a nasal to temporal direction with the IVW-1001 Ophthalmic Eyelid Wipe while applying moderate pressure to the eyelid skin slightly away from the eyelash line.
干预措施: IVW-1001 Ophthalmic Eyelid Wipe (Drug)
IVW-1001 Ophthalmic Wipe - Method 2
With eyes completely closed, the subject should wipe the upper eyelid in a nasal to temporal direction with the IVW-1001 Ophthalmic Eyelid Wipe while applying moderate pressure directly at the lash margin covering the eyelash line.
干预措施: IVW-1001 Ophthalmic Eyelid Wipe (Drug)
IVW-1001 Ophthalmic Wipe - Method 3
With eyes completely closed, the subject should lay the IVW-1001 Ophthalmic Eyelid Wipe on the upper eyelid for 5 seconds, especially over the lash margin covering the eyelash line, then wiping the upper eyelid in a nasal to temporal direction. while applying moderate pressure directly at the lash margin covering the eyelash line .
干预措施: IVW-1001 Ophthalmic Eyelid Wipe (Drug)
结局指标
主要结局
Tear production
时间窗: Day 8 for each treatment
Mean change from baseline in Unanesthetized Schirmer score
次要结局
- Visual acuity(Day 8 for each treatment)