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Dry EyePhase 4LifitegrastNCT03451396

Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

A Phase 4 study testing Lifitegrast in people with Dry Eye, run by Lifelong Vision Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine whether a fall in tear osmolarity precedes improvement in symptoms and signs of dry eye in dry eye patients treated topically with 5% lifitegrast drops for 3 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye
What is being tested?
Lifitegrast
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
12 Dec 2016to 15 Mar 2018
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Tear Osmolarity > 320 mOsm/L
  • VAS eye dryness > 40
  • No other ocular pathology
  • No contact lens wear
  • Not currently on T cell modulator
  • No change in therapy in last 2 months
  • Willingness to adhere to therapy and study visits
  • Patients qualified for prescription of lifitegrast drops

Who cannot join

  • Contact lens use
  • Eye surgery in Past 6 months
  • Use of tear supplements in past 2 hours

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lifelong Vision Foundation

    Chesterfield, Missouri, 63017

Other trials in United States

About this study

To determine whether a fall in tear osmolarity precedes improvement in symptoms and signs of dry eye in dry eye patients treated topically with 5% lifitegrast drops for 3 months.

Read the detailed description

A longitudinal, single-arm, prospective study will recruit up to 30 subjects with moderate to severe dry eye disease. Subjects will be >18 years of age, diagnosed with moderate to severe dry eye (tear osmolarity > 320 mOsm/L and Visual Analog Scale (VAS) score > 40), willing to adhere to twice daily dosing (BID) and follow up visit schedule, have no history of ocular pathology / degeneration / allergy, not on any T-cell modulatory therapy, not have instilled any artificial tears within 2 hours of study visit, and not participating in any concurrent clinical trials. All subjects will complete an informed consent form indicating their voluntary participation in the study.

Study measurements will be made at baseline (first clinic visit), 2-, 6-, and 12-weeks following Lifitegrast therapy and include tear osmolarity (TearLab osmolarity system), VAS questionnaire, slit lamp examination for fluorescein corneal staining, tear break up time (TBUT), and Meibomian gland dysfunction (MGD) grading . At the end of the 3-mo study visit, the subjects will be informed of study completion and exited from the study.

Conditions
Dry Eye
Being tested
Lifitegrast
Keywords
Dry eye, Tear osmolarity, Lifitegrast
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

    All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID

Study groups in NCT03451396
Study groupRoleWhat they receive
Mild Dry Eye CohortActive comparatorProspective 3 month study of subjects with Tear Osmolarity >308 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.
Receives: Drug: Lifitegrast
Moderate to Severe Dry Eye CohortActive comparatorProspective 3 month study of subjects with Tear Osmolarity >320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.
Receives: Drug: Lifitegrast

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary: Tear osmolarity

    Number of participants with an improvement in Tear Osmolarity measured using the Tear Osmolarity score treated with Lifitegrast.

    Measured: Baseline to the study completion, up to 3 months.

Secondary outcomes (4)

  1. VAS

    Participants self scored mean average on a scale of 0: none to 10: severe of Eye Dryness, Burning/Stinging, Foreign Body Sensation, Pain, Photophobia, Itching, and Blurred Vision.

    Measured: VAS dry eye questionnaire, tear break up time and meibomian gland grading will be serially measured over 3 months during treatment with Lifitegrast gtts

  2. Corneal Staining Grade

    Percentage of cornea with cell loss/fluorescein dye uptake. The higher the percentage the higher the grade.

    Measured: Baseline to the study completion, up to 3 months.

  3. TBUT

    Tear Film Break-Up Time; measurement of seconds it take for the tear film to start evaporating from the cornea.

    Measured: Baseline to the study completion, up to 3 months.

  4. MGD grade

    Visual grading of Meibomian gland clogging.

    Measured: Baseline to the study completion, up to 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2018
  2. Study start12 Dec 2016
  3. Primary completion1 Feb 2018
  4. Study completion15 Mar 2018

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03451396
Sponsor's protocol ID
5720
Acronym
Lifitegrast
Status last verified
Mar 2018
First submitted
1 Dec 2016
Last updated
19 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Holland EJ, Whitley WO, Sall K, Lane SS, Raychaudhuri A, Zhang SY, Shojaei A. Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials. Curr Med Res Opin. 2016 Oct;32(10):1759-1765. doi: 10.1080/03007995.2016.1210107. Epub 2016 Jul 22.

    PubMed 27388660

  • Donnenfeld ED, Karpecki PM, Majmudar PA, Nichols KK, Raychaudhuri A, Roy M, Semba CP. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study. Cornea. 2016 Jun;35(6):741-8. doi: 10.1097/ICO.0000000000000803.

    PubMed 27055211

  • Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.

    PubMed 22475641

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lifitegrast in people with Dry Eye, run by Lifelong Vision Foundation 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 8 inclusion and 3 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 19 Mar 2018. 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.

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 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?

Primary: Tear osmolarity (time frame: Baseline to the study completion, up to 3 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03451396, which also lists 3 linked publications.

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 19 Mar 2018.

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