Tear Film Markers in Dry Eye Syndrome: Impact of Immunomodulatory Therapy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Tear Film Cytokines
研究概览
简要总结
Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.
详细描述
Subjects will be recruited based on their diagnosis of dry eyes and an estimate of the severity of the disease that would be made by the investigator based on the patient's history and clinical examination.
Dry Eye Severity is determined by scoring > 12 on the Ocular Surface Disease Index (OSDI) rubric, which is standard practice.
Patients who have been diagnosed with dry eye, but who have not been prescribed a drug to treat that condition, will be recruited.
After signing a consent form, subjects will complete their routine care eye exam.
The PI will include consecutive patients for each arm. Once the mandate is completed in both arms, the investigator will stop the recruitment. The investigator will include patients who will choose to use artificial tear drops in one group. For the other group, the investigator will choose patients who would electively agree to use cyclosporine eyedrops. If these patients choose not to be a part of the study, they will still end up using the treatment that they would like to use.
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
- None
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
- •Diagnosed with Dry Eye, but who have not been prescribed a drug to treat this condition.
- •18 years of age and older
- •OSDI score > 12
排除标准
- •Younger than 18 years of age.
- •Any other associated eye diseases other than Dry Eye.
- •Inability to understand and give informed consent.
- •Patients diagnosed with Dry Eye who are already using Cequa.
研究组 & 干预措施
Cyclosporine + Artificial Tears
Cyclosporine eye drops twice daily (Treatment) with preservative-free artificial tear drops 4 times a day (Control).
干预措施: Cyclosporine (Drug)
Cyclosporine + Artificial Tears
Cyclosporine eye drops twice daily (Treatment) with preservative-free artificial tear drops 4 times a day (Control).
干预措施: Artificial tear (Drug)
Artificial Tears
Preservative-free artificial tear drops 4 times a day (Control).
干预措施: Artificial tear (Drug)
结局指标
主要结局
Tear Film Cytokines
时间窗: At the time of sample collection (Baseline and Month 6).
Change from Baseline in tear film cytokines at 6 months. The tear fluid samples would be analyzed by ELISA for: Matrix metalloproteinase-9; SLURP-1; HLA-DR5; IL-1RA; IL-6; and IL-8.
次要结局
- OSDI Score(Last follow-up (Month 6).)
研究者
Vishal Jhanji
Professor - Cornea Service
University of Pittsburgh