An Open-label, Pilot Study to Assess the Safety, Tolerability and Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in the Symptoms Associated with Band Keratopathy
研究概览
简要总结
The objective of this study is to collect preliminary efficacy and safety data on the use of EDTA EYE Drops (EED) on subjects during an episode of band keratopathy (BK).
详细描述
This study is an open-label, pilot study of up to 6 subjects with documented BK.
This study has 2 phases: In Phase 1 subjects must be willing to return to the clinic for evaluation of safety and BK symptoms during the treatment period of 6 months (Days 7, 60, 120, 180) and for follow up at Months 9 and 12. In Phase 2 subjects must be willing to return to the clinic at 18 and 24 months post-first dose for a final evaluation.
On Day 1 of the study, potential subjects will be screened and if they meet entry requirements they will be enrolled in the study.
Once enrolled, subjects will be assessed for baseline symptoms and visual acuity, have corneal photographs taken of their affected eye, dispensed EED and instructed to use it for 2 times/day for 6 months in the eye with BK. They will be dosed for the first time in the clinic in order to show them how to consistently use the drops. Subjects will also be given a diary card to record potential adverse events and pain levels (with the first level being noted in the clinic), dismissed from the clinic and reminded to return on Day 7 for assessment of tolerability and safety.
At each subsequent visit (Days 7, 60, 120, 180) the subject will be asked to rate their pain at the time of the visit on a pain analog scale. Their diary card will be reviewed for potential adverse events (AEs) and use of EED will be assessed for technique and compliance. Between visits, subjects will be called every 4 weeks by a member of the study site team to assess potential AEs and dosing compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the requirements of the study and provide informed consent prior to undergoing any study-related procedures
- •Be between the ages of 40 and 80 years old, inclusive
- •Have a documented BK diagnosis
- •Be willing and able to comply with protocol-specified dosing, visits to the clinic and tracking of symptoms
排除标准
- •Use other therapies for BK including amniotic membrane or conjunctival grafts.
- •Have other co-morbidities that may confound the safety and efficacy measurements for this study.
- •Have participated in any other clinical trial within 30 days prior to enrollment.
- •Have any condition, abnormality or situation at Baseline that in the opinion of the Principal Investigator may preclude the subject's ability to comply with study requirements, including completion of the study
研究组 & 干预措施
Drops Used
干预措施: EDTA Eye Drops (Drug)
结局指标
主要结局
Change in the Symptoms Associated with Band Keratopathy
时间窗: Days 1, 7, 60, 180, 270, 360, 540 and 720 after the start of the study.
Evaluation of pain, as rated by the subject on a visual analog scale, will be the primary symptom assessed throughout this study.
Changes of the Cornea
时间窗: Days 1, 120 and 180 after the start of the study.
Photographs will be full, direct views taken with a Zeiss model 450 plus split lamp camera.
Change in Snellen Visual Acuity
时间窗: Days 1, 7, 60, 120 and 180 after the start of the study.
The Snellen Chart is used to assess visual acuity by asking subjects to read as many of the 11 lines of block letters as they are able.
次要结局
未报告次要终点
研究者
James V. Aquavella, MD
Professor
University of Rochester