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

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease

• Study Type: Observational
• Enrollment (Actual): 946

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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.

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): August 19, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: CLIF606A1US10