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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06018571
• Other study ID #: CLIF606A1US10
• Status: Completed
• Start date: June 2, 2022
• Est. completion date: August 19, 2022

Study information

• Verified date: August 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 946
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Frequency of consultations		Up to approximately 18 months
Primary	Frequency of DED-related hospitalizations		Up to approximately 18 months
Primary	Number of emergency room (ER)/intensive care unit (ICU) admittances		Up to approximately 18 months
Primary	Duration of ER/ICU admittances		Up to approximately 18 months
Primary	Number of evaluations/tests administered		Up to approximately 18 months
Primary	Frequency of evaluations/tests administered		Up to approximately 18 months
Secondary	Number of patients with reasons for consultation, per category		Up to approximately 18 months
Secondary	Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments)		Up to approximately 18 months
Secondary	Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category		Up to approximately 18 months
Secondary	Number of patients with reasons for switching away from previous treatment line (where appropriate), per category		Up to approximately 18 months
Secondary	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
Secondary	Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score	Score range 0-100, where a higher score indicates greater satisfaction.	Up to approximately 18 months
Secondary	Number of physicians assessing reasons for choice of current treatment line, per category		Up to approximately 18 months
Secondary	Number of physicians assessing areas of improvement for current treatment line, per category		Up to approximately 18 months
Secondary	Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment		Up to approximately 18 months
Secondary	Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician		Up to approximately 18 months
Secondary	Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician		Up to approximately 18 months
Secondary	Number of physicians assessing attributes associated with ideal medication, per category		Up to approximately 18 months
Secondary	Number of physicians assessing attributes associated with currently prescribed medication, per category		Up to approximately 18 months
Secondary	Number of physicians assessing influences on treatment decisions, per category		Up to approximately 18 months