Evaluation of Lacrifill Treatment for Alleviating Dry Eye Symptoms in Post-Operative Cataract Surgery Subjects
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale)
研究概览
简要总结
Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The Principal Investigator who is completing the assessments will be masked in order to prevent biasing the study. An unmasked coordinator not involved in the assessment portion of the study will provide information to the study participant regarding the treatment and be in charge of the randomziation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age.
- •Have the potential of 20/40 visual acuity or better post-cataract surgery.
- •have cataract surgery scheduled for both eyes
- •Corneal staining score of ≥3 on the original National Eye Institute (NEI; 0-15 total score) staining scale in the study eye.
- •willing to discontinue contact lens throughout the study?
- •pre-treatment OSDI scores of ≤12 (asymptomatic)?
排除标准
- •Known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)?
- •History of ocular surgery within the past 12 months (excluding cataract surgery)
- •Anticipated complications from cataract surgery in either eye?
- •History of severe ocular trauma, active ocular infection or inflammation that is not dry eye-related?
- •Used Accutane or is currently using ocular medications/treatments outside of study treatments? Artificial tears will be allowed.
- •Physical meibomian gland treatment withing 1 month of enrollment?
- •Having any conditions or are in a situation, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.
- •Currently pregnant or breast feeding
研究组 & 干预措施
Lacrifill
Qualifying subjects will be treated with Lacrifill via the manufacturer's instructions
干预措施: Lacrifill (Drug)
Saline/Standard of care
Qualifying subjects will be treated with saline via the manufacturer's instructions
干预措施: Saline (Drug)
结局指标
主要结局
OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale)
时间窗: 1-month post operative compared to pre-treatment
Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.
次要结局
- Eye Dryness visual analog scale (VAS) Scores 1 month post operative(1 month post operative as compared to pre-treatment.)
- Eye Dryness visual analog scale (VAS) Scores 3 month post operative(3 month post operative as compared to pre-treatment.)
- • OSDI Scores at the 3-month post-operative visit compared to pre-treatment (0-100 scale).(pre-treatment as compared to 3 months post operative.)