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Company decision due to the transfer of ownership of the product
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm of DED patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifitegrast | Drug | patient newly started on medication will be followed for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients attaining 30% improvement of eye dryness from Baseline | 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). | Baseline, month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients describing eye dryness using EDS score | Eye Dryness Score (EDS) is rated using a Visual Analogue Scale (VAS) measured on a scale of 0 (no discomfort) to 100 (maximal discomfort) | 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 |
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Inclusion criteria
Exclusion criteria
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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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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C575157 | lifitegrast |
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Percentage of patients describing ocular burning/stinging, ocular pain, foreign body sensation, itching, eye discomfort, photophobia will be provided |
| Day 0, Day 1, month 3 and month 6 |
| Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to DED | Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to Dry eye disease (DED) will be provided | Day 0, Day 1, month 3 and month 6 |
| Dry Eye Questionnaire-5 (DEQ5) 5-item | The DEQ-5 consists of five questions that assess the following: frequency of watery eye, discomfort, and dryness (scored on a 0-4 scale) and late day discomfort and dryness intensity (scored on a 0 -5 scale). | Day 0, Day 1, month 3 and month 6 |
| Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels | Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels will be provided. Matrix metalloproteinase 9 is an inflammatory biomarker that has been shown to be elevated in the tears of DED patients. MMP-9 testing is a valuable diagnostic tool in identifying the presence of ocular surface inflammation in DED patients. MMP-9 level results are classified as positive or negative | Day 0, Day 1, month 3 and month 6 |
| Tear film break up time (TBUT) | Tear film break up time (TBUT) is a clinical test used to assess the evaporative dry eye disease. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film; a TBUT under 10 seconds is considered abnormal | Day 0, Day 1, month 3 and month 6 |
| Schirmer tear test (STT) score | Schirmer tear test measures maximal tear secretion capacity by assessing the amount of tears produced on filter paper in 5 minutes, with normal tear production defined as over 10 mm | Day 0, Day 1, month 3 and month 6 |
| Conjunctival and corneal staining score | The conjunctival and corneal staining score defined by the National Eye Institute grading system which divides the corneal and conjunctival surfaces to measure fluorescein uptake. Each of the 5 areas of the cornea are graded 0 to 3, with Grade 0 specifying no staining is present, for a total maximum score of 15 | Day 0, Day 1, month 3 and month 6 |
| Dry Eye Severity Level (DESL) | Based on either the symptoms or signs that point to severity of the patient, the DESL can be classified as mild, moderate or Severe | Day 0, Day 1, month 3 and month 6 |
| DED patients: Number of participants by cause/type of DED | Cause/Type of DED:
| Baseline |
| DED patients: Number of participants by ocular diseases | Ocular diseases:
| Baseline |
| DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution | DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution will be provided | Baseline |
| DED patients: Number of participants by other DED treatments received prior to therapy (concomitant use) with lifitegrast ophthalmic solution | Other DED treatments :
| Baseline |
| DED patients: Number of participants by DED-related surgical procedures received prior to lifitegrast ophthalmic solution | DED-related surgical procedures received prior to lifitegrast ophthalmic solution:
| Baseline |
| DED patients: Number of participants with non-ocular medications | DED patients: Number of participants with non-ocular medications will be provided | Baseline |
| DED patients: Number of participants by use of contact lenses | Use of contact lenses (report type of contact lenses if available):
| Baseline |
| DED patients: Number of participants by history of ocular surgery | History of ocular surgery:
| Baseline |
| DED patients: Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication | Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication will be provided | Baseline |
| DED patients: Total screen time | Total screen time (hours per day). | Baseline |
| DED patients: Number of patients wearing a mask | Wearing a mask (hours per day). | Baseline |
| DED patients: Time to treatment discontinuation | DED patients: Time to treatment discontinuation will be provided. Treatment discontinuation is defined as the time from the index date (date of initiation of lifitegrast ophthalmic solution) until the earliest of treatment discontinuation or end of the study period. | Month 6 |
| DED patients: Reason for discontinuation | DED patients: Reason for discontinuation will be provided if available | month 6 |
| DED patients: Time to add-on therapy of lifitegrast ophthalmic solution to Restasis | Time to add-on therapy of lifitegrast ophthalmic solution to Restasis (cyclosporine ophthalmic emulsion) and vice versa during the first 6 months of treatment | month 6 |
| DED patients: Percentage with treatment switch from lifitegrast ophthalmic solution | Percentage of DED patients with treatment switch from lifitegrast ophthalmic solution to other DED solutions (eg, Restasis (cyclosporine), OTC artificial tears, topical corticosteroids, antibiotics, nutraceuticals) during the first 6 months of treatment | month 6 |
| DED patients: Percentage of patients with add-on therapy of lifitegrast ophthalmic solution to Restasis | Percentage of DED patients with add-on therapy of lifitegrast ophthalmic solution to Restasis (cyclosporine ophthalmic emulsion) and vice versa during the first 6 months of treatment | month 6 |
| DED patients: Percentage of patients in treatment with lifitegrast ophthalmic solution plus other DED non-therapeutic solutions | Percentage of DED patients in treatment with lifitegrast ophthalmic solution plus other DED non-therapeutic solutions (eg, OTC artificial tears, topical corticosteroids, antibiotics, nutraceuticals) during the first 6 months of treatment | month 6 |
| DED patients: Percentage of patients with occurrence of the following DED-related surgical procedures following initiation of lifitegrast ophthalmic solution | Percentage of DED patients with occurrence of the following DED-related surgical procedures following initiation of lifitegrast ophthalmic solution during the first 6 months of observation:
| month 6 |
| Number of DED-related clinic visits (public or private) | Number of DED-related clinic visits (public or private) during the 6 months of observation | 6 months |
| Number of days absent from work during the 6 months follow-up | Number of days absent from work (absenteeism) during the 6 months follow-up. This will be measured using the Work Productivity and Activity Impairment (WPAI) questionnaire at Baseline and at 6 months. The Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) is a 6-item questionnaire that assesses work performance and daily activities performance. The WPAI scores productivity by measuring absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and impairment of daily activities (i.e., work around the house, shopping, exercising, childcare, studying). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, | Baseline, month 6 |