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

August 25, 2023 updated by: Novartis Pharmaceuticals
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
946

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores
Time Frame: 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.
Up to approximately 18 months
Work Productivity and Activity Impairment© (WPAI) mean scores
Time Frame: Up to approximately 18 months
A higher score on the WPAI indicates greater impairment and loss of productivity.
Up to approximately 18 months
Frequency of consultations
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Frequency of DED-related hospitalizations
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of emergency room (ER)/intensive care unit (ICU) admittances
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Duration of ER/ICU admittances
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of evaluations/tests administered
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Frequency of evaluations/tests administered
Time Frame: Up to approximately 18 months
Up to approximately 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with reasons for consultation, per category
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments)
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of patients with reasons for switching away from previous treatment line (where appropriate), per category
Time Frame: Up to approximately 18 months
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
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score
Time Frame: Up to approximately 18 months
Score range 0-100, where a higher score indicates greater satisfaction.
Up to approximately 18 months
Number of physicians assessing reasons for choice of current treatment line, per category
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of physicians assessing areas of improvement for current treatment line, per category
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of physicians assessing attributes associated with ideal medication, per category
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of physicians assessing attributes associated with currently prescribed medication, per category
Time Frame: Up to approximately 18 months
Up to approximately 18 months
Number of physicians assessing influences on treatment decisions, per category
Time Frame: Up to approximately 18 months
Up to approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLIF606A1US10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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