Dry Eye DiseaseNCT05857748
Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease
An observational study of Dry Eye Disease, run by Novartis Pharmaceuticals.
Trial summary
A prospective, non- interventional, observational, non-comparative, longitudinal cohort study design will be used to address the objectives of this study using data collected through a healthcare. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- lifitegrast
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2023to 30 Dec 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include newly started DED patients on lifitegrast ophthalmic solution: DED diagnosed patients who did not receive lifitegrast ophthalmic solution during the 6 months prior to the index date; that started lifitegrast ophthalmic solution during the active recruitment period. The patient will be the unit of analysis. This is critical in the inclusion/exclusion and study analysis. .
Who may be able to join
- Age ≥18 years at index date.
- Confirmed diagnosis of DED.
- Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment.
- Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months.
- Clinical decision made to initiate treatment with lifitegrast ophthalmic solution prior to enrollment in the study.
- Patient agrees to be included after signing an informed consent.
Who cannot join
- Known hypersensitivity to lifitegrast or its components.
- Dry eye secondary to scarring or destruction of conjunctival goblet cells.
- Patients with active or history of ocular herpes and or other ocular infection within the last 30 days.
- Any contra-indication as per the label.
- Refusal to give signed informed consent
About this study
Official title: Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease Receiving Lifitegrast Ophthalmic Solution in the United Arab Emirates: a Prospective Cohort
A prospective, non- interventional, observational, non-comparative, longitudinal cohort study design will be used to address the objectives of this study using data collected through a healthcare.
Read the detailed description
The study will identify patients with DED who newly initiated treatment with lifitegrast ophthalmic solution on or after the start of the recruitment period, which will last for 1 year since first patient first visit (FPFV) (index period). A minimum follow-up period of 6 months (post-index period) is set for each patient making the last patient last visit (LPLV) 6 months after the closure of recruitment period or after the last patient recruited, whichever comes first.
- Conditions
- Dry Eye Disease
- Being tested
- lifitegrast
- Keywords
- Dry eye disease, DED, NIS, United Arab Emirates
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifitegrastDrug
patient newly started on medication will be followed for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Single arm of DED patients | 1. Age ≥18 years at index date.
2. Confirmed diagnosis of DED.
3. Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment.
4. Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months. Receives: Drug: lifitegrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients attaining 30% improvement of eye dryness from Baseline
Percentage of patients attaining 30% improvement of eye dryness from Baseline at Month 3 (using the Eye Dryness Score -(EDS)). The EDS is rated using a visual analog scale (VAS) measured on a scale of 0 (no discomfort) to 100 (maximal discomfort).
Measured: Baseline, month 3
Secondary outcomes (29)
Percentage of patients describing eye dryness using EDS score
Eye Dryness Score (EDS) is rated using a Visual Analogue Scale (VAS) measured on a scale of 0 (no discomfort) to 100 (maximal discomfort)
Measured: Day 0, Day 1, month 3 and month 6
Percentage of patients describing ocular burning/stinging, ocular pain, foreign body sensation, itching, eye discomfort, photophobia
Percentage of patients describing ocular burning/stinging, ocular pain, foreign body sensation, itching, eye discomfort, photophobia will be provided
Measured: Day 0, Day 1, month 3 and month 6
Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to DED
Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to Dry eye disease (DED) will be provided
Measured: Day 0, Day 1, month 3 and month 6
Dry Eye Questionnaire-5 (DEQ5) 5-item
The DEQ-5 consists of five questions that assess the following: frequency of watery eye, discomfort, and dryness (scored on a 0-4 scale) and late day discomfort and dryness intensity (scored on a 0 -5 scale).
Measured: Day 0, Day 1, month 3 and month 6
Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels
Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels will be provided. Matrix metalloproteinase 9 is an inflammatory biomarker that has been shown to be elevated in the tears of DED patients. MMP-9 testing is a valuable diagnostic tool in identifying the presence of ocular surface inflammation in DED patients. MMP-9 level results are classified as positive or negative
Measured: Day 0, Day 1, month 3 and month 6
Tear film break up time (TBUT)
Tear film break up time (TBUT) is a clinical test used to assess the evaporative dry eye disease. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film; a TBUT under 10 seconds is considered abnormal
Measured: Day 0, Day 1, month 3 and month 6
Schirmer tear test (STT) score
Schirmer tear test measures maximal tear secretion capacity by assessing the amount of tears produced on filter paper in 5 minutes, with normal tear production defined as over 10 mm
Measured: Day 0, Day 1, month 3 and month 6
Conjunctival and corneal staining score
The conjunctival and corneal staining score defined by the National Eye Institute grading system which divides the corneal and conjunctival surfaces to measure fluorescein uptake. Each of the 5 areas of the cornea are graded 0 to 3, with Grade 0 specifying no staining is present, for a total maximum score of 15
Measured: Day 0, Day 1, month 3 and month 6
Dry Eye Severity Level (DESL)
Based on either the symptoms or signs that point to severity of the patient, the DESL can be classified as mild, moderate or Severe
Measured: Day 0, Day 1, month 3 and month 6
DED patients: Number of participants by cause/type of DED
Cause/Type of DED:
- Meibomian gland dysfunction
- Graft versus host disease
- Primary Sjögren's syndrome
- Secondary Sjögren's syndrome
- Other
Measured: Baseline
DED patients: Number of participants by ocular diseases
Ocular diseases:
- Amblyopia
- Cataract
- Glaucoma
- Macular degeneration
- Previous ocular injury
- Strabismus
- Other ocular diseases
Measured: Baseline
DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution
DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution will be provided
Measured: Baseline
DED patients: Number of participants by other DED treatments received prior to therapy (concomitant use) with lifitegrast ophthalmic solution
Other DED treatments :
- Antibiotics (eg, topical, oral)
- Cequa (cyclosporine ophthalmic solution)
- Cyclosporine
- OTC artificial tears
- Nutraceuticals (eg, fish oil)
- Restasis (cyclosporine ophthalmic emulsion)
- Topical corticosteroids
- Topical cyclosporine
- Topical cyclosporine with oral tetracycline
- Others
Measured: Baseline
DED patients: Number of participants by DED-related surgical procedures received prior to lifitegrast ophthalmic solution
DED-related surgical procedures received prior to lifitegrast ophthalmic solution:
- Punctal plugs
- Thermal pulsation treatment (eg, intense pulsed light (IPL), iLux™, Lipiflow®)
- Other DED-related surgical procedures
Measured: Baseline
DED patients: Number of participants with non-ocular medications
DED patients: Number of participants with non-ocular medications will be provided
Measured: Baseline
DED patients: Number of participants by use of contact lenses
Use of contact lenses (report type of contact lenses if available):
- Daily
- Disposable soft
- Extended wear
- Spherical
- Toric
- Other
Measured: Baseline
DED patients: Number of participants by history of ocular surgery
History of ocular surgery:
- Cataract surgery
- Corneal surgery
- Eye muscle surgery
- Glaucoma surgery
- Laser eye surgery
- Oculoplastic surgery
- Other ocular surgery
Measured: Baseline
DED patients: Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication
Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication will be provided
Measured: Baseline
DED patients: Total screen time
Total screen time (hours per day).
Measured: Baseline
DED patients: Number of patients wearing a mask
Wearing a mask (hours per day).
Measured: Baseline
DED patients: Time to treatment discontinuation
DED patients: Time to treatment discontinuation will be provided. Treatment discontinuation is defined as the time from the index date (date of initiation of lifitegrast ophthalmic solution) until the earliest of treatment discontinuation or end of the study period.
Measured: Month 6
DED patients: Reason for discontinuation
DED patients: Reason for discontinuation will be provided if available
Measured: month 6
DED patients: Time to add-on therapy of lifitegrast ophthalmic solution to Restasis
Time to add-on therapy of lifitegrast ophthalmic solution to Restasis (cyclosporine ophthalmic emulsion) and vice versa during the first 6 months of treatment
Measured: month 6
DED patients: Percentage with treatment switch from lifitegrast ophthalmic solution
Percentage of DED patients with treatment switch from lifitegrast ophthalmic solution to other DED solutions (eg, Restasis (cyclosporine), OTC artificial tears, topical corticosteroids, antibiotics, nutraceuticals) during the first 6 months of treatment
Measured: month 6
DED patients: Percentage of patients with add-on therapy of lifitegrast ophthalmic solution to Restasis
Percentage of DED patients with add-on therapy of lifitegrast ophthalmic solution to Restasis (cyclosporine ophthalmic emulsion) and vice versa during the first 6 months of treatment
Measured: month 6
DED patients: Percentage of patients in treatment with lifitegrast ophthalmic solution plus other DED non-therapeutic solutions
Percentage of DED patients in treatment with lifitegrast ophthalmic solution plus other DED non-therapeutic solutions (eg, OTC artificial tears, topical corticosteroids, antibiotics, nutraceuticals) during the first 6 months of treatment
Measured: month 6
DED patients: Percentage of patients with occurrence of the following DED-related surgical procedures following initiation of lifitegrast ophthalmic solution
Percentage of DED patients with occurrence of the following DED-related surgical procedures following initiation of lifitegrast ophthalmic solution during the first 6 months of observation:
- Punctual plugs
- Thermal pulsation treatment (IPL, iLux, Lipiflow)
- Other DED-related surgical procedures (eg, amniotic membrane placement)
Measured: month 6
Number of DED-related clinic visits (public or private)
Number of DED-related clinic visits (public or private) during the 6 months of observation
Measured: 6 months
Number of days absent from work during the 6 months follow-up
Number of days absent from work (absenteeism) during the 6 months follow-up. This will be measured using the Work Productivity and Activity Impairment (WPAI) questionnaire at Baseline and at 6 months.
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) is a 6-item questionnaire that assesses work performance and daily activities performance. The WPAI scores productivity by measuring absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and impairment of daily activities (i.e., work around the house, shopping, exercising, childcare, studying). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity,
Measured: Baseline, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start31 Jul 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Company decision due to the transfer of ownership of the product
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
- Prospective
- Enrolment
- 0 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
- NCT05857748
- Sponsor's protocol ID
- CLIF606A1AE01
- Status last verified
- Aug 2023
- First submitted
- 27 Apr 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease Receiving Lifitegrast Ophthalmic Solution in the United Arab Emirates: a Prospective Cohort
- ClinicalTrials.gov ID
- NCT05857748
- Acronym / sponsor ID
- CLIF606A1AE01
- Conditions
- Dry Eye Disease
- Keywords
- Dry eye disease, DED, NIS, United Arab Emirates
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company decision due to the transfer of ownership of the product
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 May 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.
A prospective, non- interventional, observational, non-comparative, longitudinal cohort study design will be used to address the objectives of this study using data collected through a healthcare.
Detailed description
The study will identify patients with DED who newly initiated treatment with lifitegrast ophthalmic solution on or after the start of the recruitment period, which will last for 1 year since first patient first visit (FPFV) (index period). A minimum follow-up period of 6 months (post-index period) is set for each patient making the last patient last visit (LPLV) 6 months after the closure of recruitment period or after the last patient recruited, whichever comes first.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm of DED patients | – | Drug: lifitegrast1. Age ≥18 years at index date. 2. Confirmed diagnosis of DED. 3. Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment. 4. Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include newly started DED patients on lifitegrast ophthalmic solution: DED diagnosed patients who did not receive lifitegrast ophthalmic solution during the 6 months prior to the index date; that started lifitegrast ophthalmic solution during the active recruitment period. The patient will be the unit of analysis. This is critical in the inclusion/exclusion and study analysis. .
Key inclusion criteria (6 listed)
- Age ≥18 years at index date.
- Confirmed diagnosis of DED.
- Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment.
- Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months.
- Clinical decision made to initiate treatment with lifitegrast ophthalmic solution prior to enrollment in the study.
Key exclusion criteria (5 listed)
- Known hypersensitivity to lifitegrast or its components.
- Dry eye secondary to scarring or destruction of conjunctival goblet cells.
- Patients with active or history of ocular herpes and or other ocular infection within the last 30 days.
- Any contra-indication as per the label.
- Refusal to give signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifitegrastpatient newly started on medication will be followed for 6 months | Drug | Single arm of DED patients |
Primary outcome
Percentage of patients attaining 30% improvement of eye dryness from Baseline
Time frame: Baseline, month 3
Percentage of patients attaining 30% improvement of eye dryness from Baseline at Month 3 (using the Eye Dryness Score -(EDS)). The EDS is rated using a visual analog scale (VAS) measured on a scale of 0 (no discomfort) to 100 (maximal discomfort).
29 secondary outcomes
Percentage of patients describing eye dryness using EDS score
Time frame: Day 0, Day 1, month 3 and month 6
Percentage of patients describing ocular burning/stinging, ocular pain, foreign body sensation, itching, eye discomfort, photophobia
Time frame: Day 0, Day 1, month 3 and month 6
Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to DED
Time frame: Day 0, Day 1, month 3 and month 6
Dry Eye Questionnaire-5 (DEQ5) 5-item
Time frame: Day 0, Day 1, month 3 and month 6
Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels
Time frame: Day 0, Day 1, month 3 and month 6
Tear film break up time (TBUT)
Time frame: Day 0, Day 1, month 3 and month 6
Schirmer tear test (STT) score
Time frame: Day 0, Day 1, month 3 and month 6
Conjunctival and corneal staining score
Time frame: Day 0, Day 1, month 3 and month 6
Dry Eye Severity Level (DESL)
Time frame: Day 0, Day 1, month 3 and month 6
DED patients: Number of participants by cause/type of DED
Time frame: Baseline
DED patients: Number of participants by ocular diseases
Time frame: Baseline
DED patients: Number of participants with comorbidities at time of treatment initiation with lifitegrast ophthalmic solution
Time frame: Baseline
DED patients: Number of participants by other DED treatments received prior to therapy (concomitant use) with lifitegrast ophthalmic solution
Time frame: Baseline
DED patients: Number of participants by DED-related surgical procedures received prior to lifitegrast ophthalmic solution
Time frame: Baseline
DED patients: Number of participants with non-ocular medications
Time frame: Baseline
DED patients: Number of participants by use of contact lenses
Time frame: Baseline
DED patients: Number of participants by history of ocular surgery
Time frame: Baseline
DED patients: Percentage of patients with DED baseline severity, symptoms and signs prior to the start of the medication
Time frame: Baseline
DED patients: Total screen time
Time frame: Baseline
DED patients: Number of patients wearing a mask
Time frame: Baseline
DED patients: Time to treatment discontinuation
Time frame: Month 6
DED patients: Reason for discontinuation
Time frame: month 6
DED patients: Time to add-on therapy of lifitegrast ophthalmic solution to Restasis
Time frame: month 6
DED patients: Percentage with treatment switch from lifitegrast ophthalmic solution
Time frame: month 6
DED patients: Percentage of patients with add-on therapy of lifitegrast ophthalmic solution to Restasis
Time frame: month 6
DED patients: Percentage of patients in treatment with lifitegrast ophthalmic solution plus other DED non-therapeutic solutions
Time frame: month 6
DED patients: Percentage of patients with occurrence of the following DED-related surgical procedures following initiation of lifitegrast ophthalmic solution
Time frame: month 6
Number of DED-related clinic visits (public or private)
Time frame: 6 months
Number of days absent from work during the 6 months follow-up
Time frame: Baseline, month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease, run by Novartis Pharmaceuticals.
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 6 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: withdrawn, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of patients attaining 30% improvement of eye dryness from Baseline (time frame: Baseline, month 3). 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 1 Sep 2023.