A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye: ARISE-1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Total corneal fluorescein staining score at day29
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
详细描述
Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.
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
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Have a subject reported history of dry eye for at least 6 months
- •Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
- •Have a Schirmer's Test score of ≤10mm and ≥1mm
- •Have a Tear Film Break-Up Time (TFBUT) ≤10 seconds
- •Have a corneal fluorescein staining score of ≥2 in at least one region of the cornea
排除标准
- •Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months;
- •Have an IOP > 25 mmHg at Visit 1;
- •Have any planned ocular and/or lid surgeries over the study period;
- •Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
- •Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study);
- •Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;
研究组 & 干预措施
High Dose RGN-259
High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
干预措施: RGN-259 (Drug)
Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
干预措施: Placebo (Drug)
Low Dose RGN-259
Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
干预措施: RGN-259 (Drug)
结局指标
主要结局
Total corneal fluorescein staining score at day29
时间窗: 29 days after first dosing
Total ocular discomfort score at day29
时间窗: 29 days after first dosing
次要结局
- Unanesthetized Schirmer's Test at day 8, 15, 29(8, 15, 29 days after first dosing)
- Tear film break-up time at day 8, 15, 29(8, 15, 29 days after first dosing)
- Ocular Surface Disease Index (OSDI)© at day 8, 15, 29(8, 15, 29 days after first dosing)