Clinical trial NCT03451396: Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms
Official title: Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Dry eye
Tear osmolarity
Lifitegrast
Lead sponsor: Lifelong Vision Foundation
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Primary: Tear osmolarity
timeFrame: Baseline to the study completion, up to 3 months.
Secondary outcomes:
measure: VAS
timeFrame: VAS dry eye questionnaire, tear break up time and meibomian gland grading will be serially measured over 3 months during treatment with Lifitegrast gtts
measure: Corneal Staining Grade
timeFrame: Baseline to the study completion, up to 3 months.
measure: TBUT
timeFrame: Baseline to the study completion, up to 3 months.
measure: MGD grade
timeFrame: Baseline to the study completion, up to 3 months.
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
Study officials:
affiliation: Pepose Vision Institute
name: Jay S Pepose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.