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

NCT06018571 | Completed

• 1 other identifier: CLIF606A1US10
• Study Type: observational
• Target: 946
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (14)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 30, 2023
• Study Start: June 2, 2022
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

US (1)