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Completed

NCT Number: NCT06018571

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).

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores

    Time frame: Up to approximately 18 months

    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.

  2. Work Productivity and Activity Impairment© (WPAI) mean scores

    Time frame: Up to approximately 18 months

    A higher score on the WPAI indicates greater impairment and loss of productivity.

  3. Frequency of consultations

    Time frame: Up to approximately 18 months

  4. Frequency of DED-related hospitalizations

    Time frame: Up to approximately 18 months

  5. Number of emergency room (ER)/intensive care unit (ICU) admittances

    Time frame: Up to approximately 18 months

  6. Duration of ER/ICU admittances

    Time frame: Up to approximately 18 months

  7. Number of evaluations/tests administered

    Time frame: Up to approximately 18 months

  8. Frequency of evaluations/tests administered

    Time frame: Up to approximately 18 months

Secondary outcomes

  1. Number of patients with reasons for consultation, per category

    Time frame: Up to approximately 18 months

  2. Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments)

    Time frame: Up to approximately 18 months

  3. Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category

    Time frame: Up to approximately 18 months

  4. Number of patients with reasons for switching away from previous treatment line (where appropriate), per category

    Time frame: Up to approximately 18 months

  5. Number of patients with "other than cure their DED, the most important benefit a drug treatment could provide," per category

    Time frame: Up to approximately 18 months

  6. Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score

    Time frame: Up to approximately 18 months

    Score range 0-100, where a higher score indicates greater satisfaction.

  7. Number of physicians assessing reasons for choice of current treatment line, per category

    Time frame: Up to approximately 18 months

  8. Number of physicians assessing areas of improvement for current treatment line, per category

    Time frame: Up to approximately 18 months

  9. Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment

    Time frame: Up to approximately 18 months

  10. Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician

    Time frame: Up to approximately 18 months

  11. Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician

    Time frame: Up to approximately 18 months

  12. Number of physicians assessing attributes associated with ideal medication, per category

    Time frame: Up to approximately 18 months

  13. Number of physicians assessing attributes associated with currently prescribed medication, per category

    Time frame: Up to approximately 18 months

  14. Number of physicians assessing influences on treatment decisions, per category

    Time frame: Up to approximately 18 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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