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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06018571
Other study ID # CLIF606A1US10
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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