Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06018571
Enrollment
946
Registered
2023-08-30
Start date
2022-06-02
Completion date
2022-08-19
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

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).

Interventions

None listed

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scoresUp to approximately 18 monthsMean 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.
Work Productivity and Activity Impairment© (WPAI) mean scoresUp to approximately 18 monthsA higher score on the WPAI indicates greater impairment and loss of productivity.
Frequency of consultationsUp to approximately 18 months
Frequency of DED-related hospitalizationsUp to approximately 18 months
Number of emergency room (ER)/intensive care unit (ICU) admittancesUp to approximately 18 months
Duration of ER/ICU admittancesUp to approximately 18 months
Number of evaluations/tests administeredUp to approximately 18 months
Frequency of evaluations/tests administeredUp to approximately 18 months

Secondary

MeasureTime frameDescription
Number of patients for whom cost/reimbursement was a driving factor in selection of current treatmentUp to approximately 18 months
Number of patients who were adherent to their current treatment plan, per category, as assessed by the physicianUp to approximately 18 months
Number of patients who were compliant to their current treatment plan, per category, as assessed by the physicianUp to approximately 18 months
Number of patients with reasons for consultation, per categoryUp to approximately 18 months
Number of physicians assessing attributes associated with currently prescribed medication, per categoryUp to approximately 18 months
Number of physicians assessing influences on treatment decisions, per categoryUp to approximately 18 months
Number of physicians assessing attributes associated with ideal medication, per categoryUp 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 categoryUp to approximately 18 months
Number of patients with reasons for switching away from previous treatment line (where appropriate), per categoryUp to approximately 18 months
Number of patients with other than cure their DED, the most important benefit a drug treatment could provide, per categoryUp to approximately 18 months
Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean scoreUp to approximately 18 monthsScore range 0-100, where a higher score indicates greater satisfaction.
Number of physicians assessing reasons for choice of current treatment line, per categoryUp to approximately 18 months
Number of physicians assessing areas of improvement for current treatment line, per categoryUp to approximately 18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026