Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease

Novartis Pharmaceuticals

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Dry Eye Disease

Interventions

lifitegrastDRUG

patient newly started on medication will be followed for 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Baseline, month 3

Secondary Outcomes

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)