Evaluation of a Novel Ocular Lubricating Eye Drop
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The objective of this 2-part study is to assess the safety and tolerability of the new ocular lubricating drop ABR2 during short-term use in subjects for the temporary relief of ocular discomfort due to dryness of the eye.
In Part 1, participant will receive 1 drop of ABR2 in one eye and through assessments over a 1-hour period.
In Part 2, participant will use 1 drop of ABR2 at least two times a day for 28-day period (may use up to 4 times a day as needed) This is a single arm, open label study with no placebo or comparative arm.
详细描述
Part 1 has a total of 2 scheduled visits, including Screening and Treatment visit. Participants will attend Part 1 for a total of 3.0 hours.
Part 2 has a total of 6 scheduled visits, including the Screening, baseline & dispense visit, day 3, 1-week, 2-week, and 4-week Follow Up. Participants will attend Part 2 for a total of 6.5 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Are at least 18 years of age and have capacity to volunteer
- •Are able to read (Part 2 only);
- •Have signed an information and consent letter;
- •Are willing to follow instructions and maintain the appointment schedule;
- •Are willing to refrain from contact lens wear throughout the study period;
- •Have a best corrected visual acuity of +0.20 LogMAR or better in each eye;
- •Have an OSDI score ≥13 AND at least one of the following signs in at least one eye: Non-invasive tear film break-up time (NITBUT) < 10 sec, AND/OR ocular surface staining (> 5 corneal spots, and/ or > 9 conjunctival spots)
排除标准
- •Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days;
- •Have a known active ocular disease and/ or infection with the exception of dry eye disease;
- •Have any slit lamp findings that would contraindicate use of the study product;
- •Have a systemic condition that would contraindicate use of the study product;
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Have undergone refractive error surgery or intraocular surgery within the last 12 months;
- •Have any known sensitivity or allergy to the diagnostic sodium fluorescein or to any ingredients in the study product;
- •Are using ocular lubricating eye drops more than twice per day on a typical day over the past month (Part 2 only);
- •Are an employee of the Centre for Ocular Research & Education directly involved in this study