Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 946
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

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).


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.

Primary outcomes:
measure: Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores
timeFrame: Up to approximately 18 months
measure: Work Productivity and Activity Impairment© (WPAI) mean scores
timeFrame: Up to approximately 18 months
measure: Frequency of consultations
timeFrame: Up to approximately 18 months
measure: Frequency of DED-related hospitalizations
timeFrame: Up to approximately 18 months
measure: Number of emergency room (ER)/intensive care unit (ICU) admittances
timeFrame: Up to approximately 18 months
measure: Duration of ER/ICU admittances
timeFrame: Up to approximately 18 months
measure: Number of evaluations/tests administered
timeFrame: Up to approximately 18 months
measure: Frequency of evaluations/tests administered
timeFrame: Up to approximately 18 months
Secondary outcomes:
measure: Number of patients with reasons for consultation, per category
timeFrame: Up to approximately 18 months
measure: Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments)
timeFrame: Up to approximately 18 months
measure: Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category
timeFrame: Up to approximately 18 months
measure: Number of patients with reasons for switching away from previous treatment line (where appropriate), per category
timeFrame: Up to approximately 18 months
measure: Number of patients with "other than cure their DED, the most important benefit a drug treatment could provide," per category
timeFrame: Up to approximately 18 months
measure: Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score
timeFrame: Up to approximately 18 months
measure: Number of physicians assessing reasons for choice of current treatment line, per category
timeFrame: Up to approximately 18 months
measure: Number of physicians assessing areas of improvement for current treatment line, per category
timeFrame: Up to approximately 18 months
measure: Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment
timeFrame: Up to approximately 18 months
measure: Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician
timeFrame: Up to approximately 18 months
measure: Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician
timeFrame: Up to approximately 18 months
measure: Number of physicians assessing attributes associated with ideal medication, per category
timeFrame: Up to approximately 18 months
measure: Number of physicians assessing attributes associated with currently prescribed medication, per category
timeFrame: Up to approximately 18 months
measure: Number of physicians assessing influences on treatment decisions, per category
timeFrame: Up to approximately 18 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: