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
Overview
- Phase
- N/A
- Intervention
- lifitegrast
- Conditions
- Dry Eye Disease
- Sponsor
- Novartis Pharmaceuticals
- Primary Endpoint
- Percentage of patients attaining 30% improvement of eye dryness from Baseline
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Single arm of DED patients
1. Age ≥18 years at index date. 2. Confirmed diagnosis of DED. 3. Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment. 4. Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months.
Intervention: lifitegrast
Outcomes
Primary Outcomes
Percentage of patients attaining 30% improvement of eye dryness from Baseline
Time Frame: 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).
Secondary Outcomes
- 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)