Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing.
The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010).
The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.
详细描述
See above
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schirmers of < 5 mm at 5 minutes
- •TFBUT: less than 10 seconds
- •Corneal staining of >3 of 15: conjunctival staining of >3 of 18
- •Ocular Surface Disease Index of > 50
- •Presumed best corrected vision of 20/60 or better
排除标准
- •Acute or inflammatory corneal disease
- •Pregnancy or lactation
- •Monocular status
- •Punctal occlusion within 30 days
- •Ocular surgery within 3 months
- •Corneal thinning of >50%
- •Active corneal infection
- •History of ocular malignancy
- •Retinal neovascularization
- •Current use of topical cyclosporin A
研究组 & 干预措施
Thymosin Beta 4 eye drops
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days
干预措施: Thymosin Beta 4 eye drops (Drug)
Vehicle Control
It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days.
干预措施: Vehicle Control (Drug)
结局指标
主要结局
Safety
时间窗: Day 1, Day 14, Day 28 and Day 56
Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).
次要结局
- Corneal Fluorescein Staining(Days 56 (+28 day follow up))
- Tear Film Break up Time(Days 56 (+28 day follow up))
- Ocular Discomfort Index(Days 56 (+28 day follow up))
研究者
Steven P. Dunn, M.D.
Principal Investigator
Michigan Cornea Consultants, PC