NCT03451396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

December 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

December 1, 2016

Last Update Submit

March 16, 2018

Conditions

Dry Eye

Keywords

Dry eyeTear osmolarityLifitegrast

Outcome Measures

Primary Outcomes (1)

  • Primary: Tear osmolarity

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

    Baseline to the study completion, up to 3 months.

Secondary Outcomes (4)

  • VAS

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

  • Corneal Staining Grade

    Baseline to the study completion, up to 3 months.

  • TBUT

    Baseline to the study completion, up to 3 months.

  • MGD grade

    Baseline to the study completion, up to 3 months.

Study Arms (2)

Mild Dry Eye Cohort

ACTIVE COMPARATOR

Prospective 3 month study of subjects with Tear Osmolarity \>308 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.

Drug: Lifitegrast

Moderate to Severe Dry Eye Cohort

ACTIVE COMPARATOR

Prospective 3 month study of subjects with Tear Osmolarity \>320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.

Drug: Lifitegrast

Interventions

LifitegrastDRUG

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

Mild Dry Eye CohortModerate to Severe Dry Eye Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lifelong Vision Foundation

Chesterfield, Missouri, 63017, United States

Location

Related Publications (3)

  • 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.

    PMID: 27388660RESULT

  • 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.

    PMID: 27055211RESULT

  • 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.

    PMID: 22475641RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Jay S Pepose, MD, PhD

    Pepose Vision Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2016

First Posted

March 1, 2018

Study Start

December 12, 2016

Primary Completion

February 1, 2018

Study Completion

March 15, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

US(1)