Safety and Efficacy Of Recombinant Human Deoxyribonuclease Eye Drops In Patients With Sjogren's and Non-Sjogren Dry Eye Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and preliminary efficacy of DNase eye drops in patients with Sjogren's and Non-Sjogren 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Capable of giving informed consent and does provide informed consent.
- •Documented Dry Eye Disease for at least 6 months.
- •Schirmer I <10
- •Corneal/ conjunctival (Rose Bengal) staining ≥1
- •Ocular symptoms must be considered as annoying or activity limiting (OSDI ≥13; mild).
- •Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study.
排除标准
- •Allergic to Deoxyribonuclease eye drops or any similar products, or excipients of Deoxyribonuclease eye drops 0.1%.
- •Receiving or have received within 30 days any experimental systemic medication.
- •Active ocular infection or ocular allergies.
- •Any history of eyelid surgery or ocular surgery within the past 3 months.
- •Corneal epithelial defect larger than 1 mm2 in either eye.
- •The use of topical cyclosporine or corticosteroids within 2 weeks of enrollment
- •Have active drug/alcohol dependence or abuse history
研究组 & 干预措施
DNase
DNase 0.1% eye drops four times a day for 8 weeks
干预措施: DNase (Drug)
Vehicle
Drug vehicle eye drops four times a day for 8 weeks
干预措施: Vehicle (Drug)
结局指标
主要结局
The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining
时间窗: Between baseline and at 8 weeks of treatment
Corneal staining score as measured by Rose Bengal (RB) dye staining using National Eye Institute (NEI) 1995 workshop grading scale. The dye was applied to each eye and a slit lamp was used to observe corneal staining. The NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores, for a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with RB dye defined as a score of 0 indicating the best outcome.
The Change in the Ocular Surface Disease Index Score
时间窗: Between baseline and at 8 weeks of treatment
Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and \>33 being severe DED. OSDI=\[(sum of scores for questions answered)×100\]/\[(total questions answered)×4\]
次要结局
未报告次要终点
研究者
Sandeep Jain, MD
Associate Professor of Ophthalmology
University of Illinois at Chicago