Dry Eye DiseaseNCT06018571
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
An observational study of Dry Eye Disease, run by Novartis Pharmaceuticals at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- How many people
- 946 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 19 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Dry Eye Disease
- Medical subject headings
- Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 18 months
Work Productivity and Activity Impairment© (WPAI) mean scores
A higher score on the WPAI indicates greater impairment and loss of productivity.
Measured: Up to approximately 18 months
Frequency of consultations
Measured: Up to approximately 18 months
Frequency of DED-related hospitalizations
Measured: Up to approximately 18 months
Number of emergency room (ER)/intensive care unit (ICU) admittances
Measured: Up to approximately 18 months
Duration of ER/ICU admittances
Measured: Up to approximately 18 months
Number of evaluations/tests administered
Measured: Up to approximately 18 months
Frequency of evaluations/tests administered
Measured: Up to approximately 18 months
Secondary outcomes (14)
Number of patients with reasons for consultation, per category
Measured: Up to approximately 18 months
Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments)
Measured: Up to approximately 18 months
Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category
Measured: Up to approximately 18 months
Number of patients with reasons for switching away from previous treatment line (where appropriate), per category
Measured: 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
Measured: Up to approximately 18 months
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.
Measured: Up to approximately 18 months
Number of physicians assessing reasons for choice of current treatment line, per category
Measured: Up to approximately 18 months
Number of physicians assessing areas of improvement for current treatment line, per category
Measured: Up to approximately 18 months
Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment
Measured: Up to approximately 18 months
Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician
Measured: Up to approximately 18 months
Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician
Measured: Up to approximately 18 months
Number of physicians assessing attributes associated with ideal medication, per category
Measured: Up to approximately 18 months
Number of physicians assessing attributes associated with currently prescribed medication, per category
Measured: Up to approximately 18 months
Number of physicians assessing influences on treatment decisions, per category
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start2 Jun 2022
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 946 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018571
- Sponsor's protocol ID
- CLIF606A1US10
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06018571
- Acronym / sponsor ID
- CLIF606A1US10
- Conditions
- Dry Eye Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 946 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (7 listed)
- ≥ 18 years of age.
- Physician-confirmed DED diagnosis (at time of data collection).
- ≥ 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).
Key exclusion criteria (5 listed)
- Involved in a DED clinical trial (at time of data collection).
- Involved in a DED clinical trial (at time of data collection).
- Included in the main sample previously.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Frequency of consultations
Time frame: Up to approximately 18 months
Frequency of DED-related hospitalizations
Time frame: Up to approximately 18 months
Number of emergency room (ER)/intensive care unit (ICU) admittances
Time frame: Up to approximately 18 months
Duration of ER/ICU admittances
Time frame: Up to approximately 18 months
Number of evaluations/tests administered
Time frame: Up to approximately 18 months
Frequency of evaluations/tests administered
Time frame: Up to approximately 18 months
14 secondary outcomes
Number of patients with reasons for consultation, per category
Time frame: 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
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
Number of patients with reasons for switching away from previous treatment line (where appropriate), per category
Time frame: 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
Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score
Time frame: 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
Number of physicians assessing areas of improvement for current treatment line, per category
Time frame: 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
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
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
Number of physicians assessing attributes associated with ideal medication, per category
Time frame: Up to approximately 18 months
Number of physicians assessing attributes associated with currently prescribed medication, per category
Time frame: Up to approximately 18 months
Number of physicians assessing influences on treatment decisions, per category
Time frame: Up to approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores (time frame: Up to approximately 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.