Ocular DiscomfortPhase 4NCT03408015
Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease
A Phase 4 study testing Lifitegrast in people with Ocular Discomfort and Ocular Inflammation, run by University of Alabama at Birmingham.
Trial summary
Every night during sleep, there is an accumulation of white blood cells in the closed eye. The closed eye white blood cells are predominantly neutrophils, but there is a small population (3%) of T cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Discomfort, Ocular Inflammation, Dry Eye
- What is being tested?
- Lifitegrast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to 30 Jan 2019
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and sign an informed consent and HIPAA privacy document
- Greater than 18 years of age at time of informed consent
- Able and willing to follow protocol instructions
- Capable of performing at-home eye wash
- Must be willing to drop off samples and comply with study visit procedures
- For contact lens wearers, must wear lenses at least four hours per day, four days per week
Who cannot join
- Current cigarette smokers
- Current participation in any investigational drug or device study. If subjects choose to participate in another investigational drug or device study, they will be discontinued from this study protocol.
- Current pregnancy or nursing as indicated by self-report. While not a safety issue, pregnancy or nursing influences the biochemical composition of the tear film.
- Any systemic health conditions that alter tear film physiology
- A history of ocular surgery within the past 12 months
- Any active ocular infection or inflammation
Show all 12Show fewer
- Any present use of Accutane or ocular medications
- Any history of significant adverse reaction to lifitegrast or other components of the drug product, or contraindication to the use of lifitegrast or other components of the drug product
- Any prior exposure to lifitegrast.
- For normal and dry eye subjects, any history of contact lens wear within the past three months.
- For contact lens wearers, any change of soft contact lens brand or care solutions within 30 days prior to screening or any anticipation of changing current type/brand of contact lenses or care solutions throughout the 84 day study
- Any condition, which in the examiner's opinion, may put the subject at significant risk, confound study results, or interfere with their participation in the study.
About this study
Every night during sleep, there is an accumulation of white blood cells in the closed eye. The closed eye white blood cells are predominantly neutrophils, but there is a small population (3%) of T cells. The effects of these closed eye white blood cells on dry eye disease pathogenesis have yet to be fully elucidated, but preliminary evidence suggests that closed eye neutrophils may have an associated hyperactivity and increased degranulation in dry eye disease that could contribute to epithelial instability. As an anti-T cell therapy, Xiidra offers an opportunity to better understand how the closed eye white blood cells are recruited and activated. This study also seeks to verify the proposed mechanism of action.
- Conditions
- Ocular Discomfort, Ocular Inflammation, Dry Eye, Contact Lens Complication, Keratoconjunctivitis Sicca
- Being tested
- Lifitegrast
- Keywords
- dry eye disease, neutrophil, T cell, lifitegrast, contact lens discomfort, ocular surface homeostasis
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifitegrastDrug
Also called Xiidra
Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.
| Study group | Role | What they receive |
|---|---|---|
| Normal, asymptomatic non-lens wearers | Experimental | Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed. Receives: Drug: Lifitegrast |
| Dry eye subjects, non-lens wearers | Experimental | Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed. Receives: Drug: Lifitegrast |
| Contact lens wearers with discomfort | Experimental | Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed. Receives: Drug: Lifitegrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total number of T cells recovered from the closed eye to day 84
Subjects will be trained and required to collect their closed eye tears at home, using a gentle saline rinse of the ocular surface. Enumeration of recovered T cells will be performed by flow cytometry.
Measured: Baseline to day 84
Secondary outcomes (1)
Change from baseline in the total number of neutrophils recovered from the closed eye to day 84.
Subjects will be trained and required to collect their closed eye tears at home, using a gentle saline rinse of the ocular surface. Enumeration of recovered neutrophils will be performed by flow cytometry.
Measured: Baseline to day 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startJan 2019 (estimated)
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Why it stopped: Study timing was poor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular DiscomfortStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Three groups of individuals will be recruited: asymptomatic non-contact lens wearers; symptomatic non-contact lens wearers, with dry eye disease; symptomatic contact lens wearers, with contact lens discomfort. All three groups will receive the same Xiidra treatment for the complete study duration.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Kelly Nichols, University of Alabama at Birmingham
- Investigators
- Kelly K Nichols, OD MPH PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408015
- Sponsor's protocol ID
- 300001139
- Status last verified
- May 2019
- First submitted
- 17 Jan 2018
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT03408015
- Acronym / sponsor ID
- 300001139
- Conditions
- Ocular Discomfort, Ocular Inflammation, Dry Eye, Contact Lens Complication, Keratoconjunctivitis Sicca
- Keywords
- dry eye disease, neutrophil, T cell, lifitegrast, contact lens discomfort, ocular surface homeostasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study timing was poor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Jan 2019 (estimated)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 23 Jan 2018 (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.
Every night during sleep, there is an accumulation of white blood cells in the closed eye. The closed eye white blood cells are predominantly neutrophils, but there is a small population (3%) of T cells. The effects of these closed eye white blood cells on dry eye disease pathogenesis have yet to be fully elucidated, but preliminary evidence suggests that closed eye neutrophils may have an associated hyperactivity and increased degranulation in dry eye disease that could contribute to epithelial instability. As an anti-T cell therapy, Xiidra offers an opportunity to better understand how the closed eye white blood cells are recruited and activated. This study also seeks to verify the proposed mechanism of action.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups of individuals will be recruited: asymptomatic non-contact lens wearers; symptomatic non-contact lens wearers, with dry eye disease; symptomatic contact lens wearers, with contact lens discomfort. All three groups will receive the same Xiidra treatment for the complete study duration.
| Arm | Type | Receives |
|---|---|---|
| Normal, asymptomatic non-lens wearers | Experimental | Drug: LifitegrastLifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed. |
| Dry eye subjects, non-lens wearers | Experimental | Drug: LifitegrastLifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed. |
| Contact lens wearers with discomfort | Experimental | Drug: LifitegrastLifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand and sign an informed consent and HIPAA privacy document
- Greater than 18 years of age at time of informed consent
- Able and willing to follow protocol instructions
- Capable of performing at-home eye wash
- Must be willing to drop off samples and comply with study visit procedures
Key exclusion criteria (12 listed)
- Current cigarette smokers
- Current participation in any investigational drug or device study. If subjects choose to participate in another investigational drug or device study, they will be discontinued from this study protocol.
- Current pregnancy or nursing as indicated by self-report. While not a safety issue, pregnancy or nursing influences the biochemical composition of the tear film.
- Any systemic health conditions that alter tear film physiology
- A history of ocular surgery within the past 12 months
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 |
|---|---|---|
| LifitegrastAlso: XiidraLifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed. | Drug | Contact lens wearers with discomfort, Dry eye subjects, non-lens wearers, Normal, asymptomatic non-lens wearers |
Primary outcome
Change from baseline in the total number of T cells recovered from the closed eye to day 84
Time frame: Baseline to day 84
Subjects will be trained and required to collect their closed eye tears at home, using a gentle saline rinse of the ocular surface. Enumeration of recovered T cells will be performed by flow cytometry.
1 secondary outcome
Change from baseline in the total number of neutrophils recovered from the closed eye to day 84.
Time frame: Baseline to day 84.
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 17 May 2019.
- 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.
Kelly K Nichols, OD MPH PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lifitegrast in people with Ocular Discomfort and Ocular Inflammation, run by University of Alabama at Birmingham.
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 12 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 17 May 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in the total number of T cells recovered from the closed eye to day 84 (time frame: Baseline to day 84). 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 17 May 2019.