Patient Experience Study Evaluating The Effect of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and QOL in Patients With Mild to Moderate DED and High Digital Device Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change from Baseline in Current Symptom Score
研究概览
简要总结
Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) in adult participants with dry eye symptoms and who are high digital device users.
NGE-UD is an over-the-counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of NGE-UD on Day 1 for the acute phase of the study, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Around 50 adult participants will be enrolled at one site in the United States.
There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site as per standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •During a routine visit, investigator will decide whether artificial tears are the appropriate treatment for potential participants with dry eyes and will then consider enrollment into this study.
- •Participant with at least one sign of dry eye:
- •Three consecutive tear break-up time (TBUT) tests <= 10 seconds in at least one eye at Screening Visit OR;
- •Grade 1 to 4 (modified National Eye Institute [NEI] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at both at Screening Visit.
- •Use of digital devices of 8 hours or more per day.
- •Adult participants who answer yes to the following questions:
- •Do you use digital devices at least 8 hours per day? Yes or No
- •Are your eyes dry, irritated while using a digital screen like a computer or smartphone? Yes or No
排除标准
- •Use of artificial tears in the last 24 hours.
- •Current use of more than 4 drops of artificial tears per day in each eye.
- •Use of dry eye treatment other than artificial tears.
- •Are currently on ocular medications.
研究组 & 干预措施
NGE-UD
Participants will receive one drop of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Day 1, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15.
干预措施: Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) (Drug)
结局指标
主要结局
Change from Baseline in Current Symptom Score
时间窗: Baseline to Day 15
The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the current moment using a scale ranging from '0 = strongly disagree' to '100 = strongly agree.'
Change from Baseline in Ocular Surface Disease Index (OSDI) Score
时间窗: Baseline to Day 15
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time to 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability to 100=complete disability). A negative number change from baseline represents an improvement.
次要结局
未报告次要终点