Dry Eye Disease
Conditions
Keywords
Dry eye disease, DED, NIS, United Arab Emirates
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.
Interventions
DRUGlifitegrast
patient newly started on medication will be followed for 6 months
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients attaining 30% improvement of eye dryness from Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Percentage of patients describing ocular burning/stinging, ocular pain, foreign body sensation, itching, eye discomfort, photophobia will be provided |
| 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 | Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to Dry eye disease (DED) will be provided |
| Dry Eye Questionnaire-5 (DEQ5) 5-item | Day 0, Day 1, month 3 and month 6 | 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). |
| Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels | Day 0, Day 1, month 3 and month 6 | 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 |
| Tear film break up time (TBUT) | Day 0, Day 1, month 3 and month 6 | 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 |
| Schirmer tear test (STT) score | Day 0, Day 1, month 3 and month 6 | 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 |
| Conjunctival and corneal staining score | Day 0, Day 1, month 3 and month 6 | 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 |
| Dry Eye Severity Level (DESL) | Day 0, Day 1, month 3 and month 6 | Based on either the symptoms or signs that point to severity of the patient, the DESL can be classified as mild, moderate or Severe |
| DED patients: Number of participants by cause/type of DED | Baseline | Cause/Type of DED: * Meibomian gland dysfunction * Graft versus host disease * Primary Sjögren's syndrome * Secondary Sjögren's syndrome * Other |
| DED patients: Number of participants by ocular diseases | Baseline | Ocular diseases: * Amblyopia * Cataract * Glaucoma * Macular degeneration * Previous ocular injury * Strabismus * Other ocular diseases |
| DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution | Baseline | DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution will be provided |
| DED patients: Number of participants by other DED treatments received prior to therapy (concomitant use) with lifitegrast ophthalmic solution | Baseline | Other DED treatments : * Antibiotics (eg, topical, oral) * Cequa (cyclosporine ophthalmic solution) * Cyclosporine * OTC artificial tears * Nutraceuticals (eg, fish oil) * Restasis (cyclosporine ophthalmic emulsion) * Topical corticosteroids * Topical cyclosporine * Topical cyclosporine with oral tetracycline * Others |
| DED patients: Number of participants by DED-related surgical procedures received prior to lifitegrast ophthalmic solution | Baseline | DED-related surgical procedures received prior to lifitegrast ophthalmic solution: * Punctal plugs * Thermal pulsation treatment (eg, intense pulsed light (IPL), iLux™, Lipiflow®) * Other DED-related surgical procedures |
| DED patients: Number of participants with non-ocular medications | Baseline | DED patients: Number of participants with non-ocular medications will be provided |
| Percentage of patients describing eye dryness using EDS score | Day 0, Day 1, month 3 and month 6 | Eye Dryness Score (EDS) is rated using a Visual Analogue Scale (VAS) measured on a scale of 0 (no discomfort) to 100 (maximal discomfort) |
| DED patients: Number of participants by history of ocular surgery | Baseline | History of ocular surgery: * Cataract surgery * Corneal surgery * Eye muscle surgery * Glaucoma surgery * Laser eye surgery * Oculoplastic surgery * Other ocular surgery |
| DED patients: Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication | Baseline | Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication will be provided |
| DED patients: Total screen time | Baseline | Total screen time (hours per day). |
| DED patients: Number of patients wearing a mask | Baseline | Wearing a mask (hours per day). |
| DED patients: Time to treatment discontinuation | Month 6 | 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. |
| DED patients: Reason for discontinuation | month 6 | DED patients: Reason for discontinuation will be provided if available |
| DED patients: Time to add-on therapy of lifitegrast ophthalmic solution to Restasis | month 6 | Time to add-on therapy of lifitegrast ophthalmic solution to Restasis (cyclosporine ophthalmic emulsion) and vice versa during the first 6 months of treatment |
| DED patients: Percentage with treatment switch from lifitegrast ophthalmic solution | month 6 | 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 |
| DED patients: Percentage of patients with add-on therapy of lifitegrast ophthalmic solution to Restasis | month 6 | 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 |
| DED patients: Percentage of patients in treatment with lifitegrast ophthalmic solution plus other DED non-therapeutic solutions | month 6 | 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 |
| DED patients: Percentage of patients with occurrence of the following DED-related surgical procedures following initiation of lifitegrast ophthalmic solution | month 6 | 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: * Punctual plugs * Thermal pulsation treatment (IPL, iLux, Lipiflow) * Other DED-related surgical procedures (eg, amniotic membrane placement) |
| Number of DED-related clinic visits (public or private) | 6 months | Number of DED-related clinic visits (public or private) during the 6 months of observation |
| Number of days absent from work during the 6 months follow-up | Baseline, month 6 | 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, |
| DED patients: Number of participants by use of contact lenses | Baseline | Use of contact lenses (report type of contact lenses if available): * Daily * Disposable soft * Extended wear * Spherical * Toric * Other |
Outcome results
None listed