NCT07161011已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Unanesthetized Schirmer test
研究概览
简要总结
Double-masked, dose-response of two concentrations of IVW-1001
详细描述
Using the best dosing technique from Study NCT07140380, subjects will be randomized to one of two concentrations.
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 —（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 0.2%
Experimental
Ophthalmic Eyelid wipe
干预措施: IVW-1001 Ophthalmic Eyelid Wipe 0.2% (Drug)
IVW-1001 0.4%
Experimental
Ophthalmic Eyelid Wipe
干预措施: IVW-1001 Ophthalmic Eyelid Wipe 0.4% (Drug)
结局指标
主要结局
Unanesthetized Schirmer test
时间窗: 7 days
Tear production
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and AboveRespiratory Syncytial Virus (RSV)NCT06642558MAXVAX Biotechnology Limited Liability Company522
已完成
1 期
A Study Of Adjunctive Treatment Of Cognitive Deficits In SchizophreniaSchizophreniaNCT00567203Pfizer36
已完成
2 期
Study of Debio 1450 for Bacterial Skin InfectionsBacterial InfectionsNCT02426918Debiopharm International SA330
已完成
1 期
A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge ModelMalariaNCT01397227Crucell Holland BV36
已完成
2 期
Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 YearsInfluenzaNCT04192500Osivax300