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
- Conditions
- Dry Eye Disease
- Registration Number
- NCT06018571
- Lead Sponsor
- Novartis Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 946
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).
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of ER/ICU admittances Up to approximately 18 months Work Productivity and Activity Impairment© (WPAI) mean scores Up to approximately 18 months A higher score on the WPAI indicates greater impairment and loss of productivity.
Frequency of consultations Up to approximately 18 months Frequency of DED-related hospitalizations Up to approximately 18 months Number of evaluations/tests administered Up to approximately 18 months Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores 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.
Number of emergency room (ER)/intensive care unit (ICU) admittances Up to approximately 18 months Frequency of evaluations/tests administered Up to approximately 18 months
- Secondary Outcome Measures
Name Time Method Number of patients with reasons for consultation, per category 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 patients who were adherent to their current treatment plan, per category, as assessed by the physician 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 current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments) 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 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 for whom cost/reimbursement was a driving factor in selection of current treatment 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 Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score Up to approximately 18 months Score range 0-100, where a higher score indicates greater satisfaction.
Number of physicians assessing areas of improvement for current treatment line, per category 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
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States