Burden of Illness and Treatment Assessment of Patients With Dry Eye Disease: A Cross-Sectional Survey of Real-World Patients With Dry Eye Disease in the US

Study Overview
=================
Brief Summary
-----------------
This study employed secondary database analysis of the Adelphi Dry Eye Disease (DED) Disease Specific Programme™ (DSP™), a templatized cross-sectional survey with retrospective data collection that is administered by Adelphi to a convenience sample of patients diagnosed with DED, and their consulting physicians in the United States. In addition to the survey data, the DED DSP also included recorded medical history data as reported by physicians (optometrists, ophthalmologists or refractive surgeons).

Official Title
-----------------
Burden of Illness and Treatment Assessment of Patients With Dry Eye Disease: A Cross-Sectional Survey of Real-World Patients With Dry Eye Disease in the US

Conditions
-----------------
Dry Eye Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Main Sample: ≥ 18 years of age. Physician-confirmed DED diagnosis (at time of data collection). Xiidra® Oversample: ≥ 18 years of age. Physician-confirmed DED diagnosis (at time of data collection). Have a current prescription for Xiidra® for their DED (at time of data collection). Exclusion Criteria: Main Sample: • Involved in a DED clinical trial (at time of data collection). Xiidra® Oversample: Involved in a DED clinical trial (at time of data collection). Included in the main sample previously.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores | Mean IDEEL score on Symptom Bother dimension: score range 0-100, where higher scores indicate greater bother. Mean IDEEL scores on Daily Activities, Emotional Impact, and Work dimensions: score range 0-100, where higher scores indicate lesser impact. | Up to approximately 18 months | 
| Work Productivity and Activity Impairment© (WPAI) mean scores | A higher score on the WPAI indicates greater impairment and loss of productivity. | Up to approximately 18 months | 
| Frequency of consultations |  | Up to approximately 18 months | 
| Frequency of DED-related hospitalizations |  | Up to approximately 18 months | 
| Number of emergency room (ER)/intensive care unit (ICU) admittances |  | Up to approximately 18 months | 
| Duration of ER/ICU admittances |  | Up to approximately 18 months | 
| Number of evaluations/tests administered |  | Up to approximately 18 months | 
| Frequency of evaluations/tests administered |  | Up to approximately 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with reasons for consultation, per category |  | Up to approximately 18 months | 
| Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments) |  | Up to approximately 18 months | 
| Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category |  | Up to approximately 18 months | 
| Number of patients with reasons for switching away from previous treatment line (where appropriate), per category |  | Up to approximately 18 months | 
| Number of patients with other than cure their DED, the most important benefit a drug treatment could provide, per category |  | Up to approximately 18 months | 
| Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score | Score range 0-100, where a higher score indicates greater satisfaction. | Up to approximately 18 months | 
| Number of physicians assessing reasons for choice of current treatment line, per category |  | Up to approximately 18 months | 
| Number of physicians assessing areas of improvement for current treatment line, per category |  | Up to approximately 18 months | 
| Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment |  | Up to approximately 18 months | 
| Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician |  | Up to approximately 18 months | 
| Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician |  | Up to approximately 18 months | 
| Number of physicians assessing attributes associated with ideal medication, per category |  | Up to approximately 18 months | 
| Number of physicians assessing attributes associated with currently prescribed medication, per category |  | Up to approximately 18 months | 
| Number of physicians assessing influences on treatment decisions, per category |  | Up to approximately 18 months |