NCT05857748撤回不适用
Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease Receiving Lifitegrast Ophthalmic Solution in the United Arab Emirates: a Prospective Cohort
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of patients attaining 30% improvement of eye dryness from Baseline
研究概览
简要总结
A prospective, non- interventional, observational, non-comparative, longitudinal cohort study design will be used to address the objectives of this study using data collected through a healthcare.
详细描述
The study will identify patients with DED who newly initiated treatment with lifitegrast ophthalmic solution on or after the start of the recruitment period, which will last for 1 year since first patient first visit (FPFV) (index period). A minimum follow-up period of 6 months (post-index period) is set for each patient making the last patient last visit (LPLV) 6 months after the closure of recruitment period or after the last patient recruited, whichever comes first.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single arm of DED patients
- Age ≥18 years at index date.
- Confirmed diagnosis of DED.
- Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment.
- Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months.
干预措施: lifitegrast (Drug)
结局指标
主要结局
Percentage of patients attaining 30% improvement of eye dryness from Baseline
时间窗: Baseline, month 3
Percentage of patients attaining 30% improvement of eye dryness from Baseline at Month 3 (using the Eye Dryness Score -(EDS)). The EDS is rated using a visual analog scale (VAS) measured on a scale of 0 (no discomfort) to 100 (maximal discomfort).
次要结局
- DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution(Baseline)
- DED patients: Number of participants by other DED treatments received prior to therapy (concomitant use) with lifitegrast ophthalmic solution(Baseline)
- DED patients: Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication(Baseline)
- DED patients: Total screen time(Baseline)
- DED patients: Number of patients wearing a mask(Baseline)
- Tear film break up time (TBUT)(Day 0, Day 1, month 3 and month 6)
- DED patients: Number of participants by DED-related surgical procedures received prior to lifitegrast ophthalmic solution(Baseline)
- DED patients: Number of participants with non-ocular medications(Baseline)
- Schirmer tear test (STT) score(Day 0, Day 1, month 3 and month 6)
- DED patients: Number of participants by use of contact lenses(Baseline)
- Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to DED(Day 0, Day 1, month 3 and month 6)
- DED patients: Number of participants by cause/type of DED(Baseline)
- DED patients: Number of participants by history of ocular surgery(Baseline)
- Percentage of patients describing eye dryness using EDS score(Day 0, Day 1, month 3 and month 6)
- Percentage of patients describing ocular burning/stinging, ocular pain, foreign body sensation, itching, eye discomfort, photophobia(Day 0, Day 1, month 3 and month 6)
- Dry Eye Severity Level (DESL)(Day 0, Day 1, month 3 and month 6)
- Dry Eye Questionnaire-5 (DEQ5) 5-item(Day 0, Day 1, month 3 and month 6)
- Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels(Day 0, Day 1, month 3 and month 6)
- Conjunctival and corneal staining score(Day 0, Day 1, month 3 and month 6)
- DED patients: Number of participants by ocular diseases(Baseline)
- Number of DED-related clinic visits (public or private)(6 months)
- DED patients: Time to treatment discontinuation(Month 6)
- DED patients: Reason for discontinuation(month 6)
- DED patients: Time to add-on therapy of lifitegrast ophthalmic solution to Restasis(month 6)
- DED patients: Percentage of patients in treatment with lifitegrast ophthalmic solution plus other DED non-therapeutic solutions(month 6)
- DED patients: Percentage of patients with occurrence of the following DED-related surgical procedures following initiation of lifitegrast ophthalmic solution(month 6)
- DED patients: Percentage of patients with add-on therapy of lifitegrast ophthalmic solution to Restasis(month 6)
- DED patients: Percentage with treatment switch from lifitegrast ophthalmic solution(month 6)
- Number of days absent from work during the 6 months follow-up(Baseline, month 6)
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