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Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms (Lifitegrast)

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ClinicalTrials.gov Identifier: NCT03451396
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Lifelong Vision Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Lifitegrast Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears
Drug Information available for: Lifitegrast

Arm Intervention/treatment
Active Comparator: Mild Dry Eye Cohort
Prospective 3 month study of subjects with Tear Osmolarity >308 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.
Drug: Lifitegrast
All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID

Active Comparator: Moderate to Severe Dry Eye Cohort
Prospective 3 month study of subjects with Tear Osmolarity >320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.
Drug: Lifitegrast
All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID




Primary Outcome Measures :
  1. Primary: Tear osmolarity [ Time Frame: Baseline to the study completion, up to 3 months. ]
    Number of participants with an improvement in Tear Osmolarity measured using the Tear Osmolarity score treated with Lifitegrast.


Secondary Outcome Measures :
  1. VAS [ Time Frame: VAS dry eye questionnaire, tear break up time and meibomian gland grading will be serially measured over 3 months during treatment with Lifitegrast gtts ]
    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.

  2. Corneal Staining Grade [ Time Frame: Baseline to the study completion, up to 3 months. ]
    Percentage of cornea with cell loss/fluorescein dye uptake. The higher the percentage the higher the grade.

  3. TBUT [ Time Frame: Baseline to the study completion, up to 3 months. ]
    Tear Film Break-Up Time; measurement of seconds it take for the tear film to start evaporating from the cornea.

  4. MGD grade [ Time Frame: Baseline to the study completion, up to 3 months. ]
    Visual grading of Meibomian gland clogging.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451396


Locations
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United States, Missouri
Lifelong Vision Foundation
Chesterfield, Missouri, United States, 63017
Sponsors and Collaborators
Lifelong Vision Foundation
Investigators
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Principal Investigator: Jay S Pepose, MD, PhD Pepose Vision Institute

Publications of Results:
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Responsible Party: Lifelong Vision Foundation
ClinicalTrials.gov Identifier: NCT03451396     History of Changes
Other Study ID Numbers: 5720
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Lifelong Vision Foundation:
Dry eye
Tear osmolarity
Lifitegrast

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Ophthalmic Solutions
Signs and Symptoms
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lifitegrast
Pharmaceutical Solutions