Clinical trial NCT05857748: Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dry Eye Disease
Keywords: Dry eye disease
DED
NIS
United Arab Emirates
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include newly started DED patients on lifitegrast ophthalmic solution: DED diagnosed patients who did not receive lifitegrast ophthalmic solution during the 6 months prior to the index date; that started lifitegrast ophthalmic solution during the active recruitment period. The patient will be the unit of analysis. This is critical in the inclusion/exclusion and study analysis.

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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.

Eligibility criteria: Inclusion criteria

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.
5. Clinical decision made to initiate treatment with lifitegrast ophthalmic solution prior to enrollment in the study.
6. Patient agrees to be included after signing an informed consent.

Exclusion criteria

1. Known hypersensitivity to lifitegrast or its components.
2. Dry eye secondary to scarring or destruction of conjunctival goblet cells.
3. Patients with active or history of ocular herpes and or other ocular infection within the last 30 days.
4. Any contra-indication as per the label.
5. Refusal to give signed informed consent

Primary outcomes:
measure: Percentage of patients attaining 30% improvement of eye dryness from Baseline
timeFrame: Baseline, month 3
Secondary outcomes:
measure: Percentage of patients describing eye dryness using EDS score
timeFrame: Day 0, Day 1, month 3 and month 6
measure: Percentage of patients describing ocular burning/stinging, ocular pain, foreign body sensation, itching, eye discomfort, photophobia
timeFrame: Day 0, Day 1, month 3 and month 6
measure: Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to DED
timeFrame: Day 0, Day 1, month 3 and month 6
measure: Dry Eye Questionnaire-5 (DEQ5) 5-item
timeFrame: Day 0, Day 1, month 3 and month 6
measure: Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels
timeFrame: Day 0, Day 1, month 3 and month 6
measure: Tear film break up time (TBUT)
timeFrame: Day 0, Day 1, month 3 and month 6
measure: Schirmer tear test (STT) score
timeFrame: Day 0, Day 1, month 3 and month 6
measure: Conjunctival and corneal staining score
timeFrame: Day 0, Day 1, month 3 and month 6
measure: Dry Eye Severity Level (DESL)
timeFrame: Day 0, Day 1, month 3 and month 6
measure: DED patients: Number of participants by cause/type of DED
timeFrame: Baseline
measure: DED patients: Number of participants by ocular diseases
timeFrame: Baseline
measure: DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution
timeFrame: Baseline
measure: DED patients: Number of participants by other DED treatments received prior to therapy (concomitant use) with lifitegrast ophthalmic solution
timeFrame: Baseline
measure: DED patients: Number of participants by DED-related surgical procedures received prior to lifitegrast ophthalmic solution
timeFrame: Baseline
measure: DED patients: Number of participants with non-ocular medications
timeFrame: Baseline
measure: DED patients: Number of participants by use of contact lenses
timeFrame: Baseline
measure: DED patients: Number of participants by history of ocular surgery
timeFrame: Baseline
measure: DED patients: Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication
timeFrame: Baseline
measure: DED patients: Total screen time
timeFrame: Baseline
measure: DED patients: Number of patients wearing a mask
timeFrame: Baseline
measure: DED patients: Time to treatment discontinuation
timeFrame: Month 6
measure: DED patients: Reason for discontinuation
timeFrame: month 6
measure: DED patients: Time to add-on therapy of lifitegrast ophthalmic solution to Restasis
timeFrame: month 6
measure: DED patients: Percentage with treatment switch from lifitegrast ophthalmic solution
timeFrame: month 6
measure: DED patients: Percentage of patients with add-on therapy of lifitegrast ophthalmic solution to Restasis
timeFrame: month 6
measure: DED patients: Percentage of patients in treatment with lifitegrast ophthalmic solution plus other DED non-therapeutic solutions
timeFrame: month 6
measure: DED patients: Percentage of patients with occurrence of the following DED-related surgical procedures following initiation of lifitegrast ophthalmic solution
timeFrame: month 6
measure: Number of DED-related clinic visits (public or private)
timeFrame: 6 months
measure: Number of days absent from work during the 6 months follow-up
timeFrame: Baseline, month 6
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: