NCT03952481

Brief Summary

The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

May 10, 2019

Last Update Submit

February 10, 2021

Conditions

Dry EyeDry Eye SyndromesDry Eyes Chronic

Keywords

Dry EyeLifitegrastXiidra

Outcome Measures

Primary Outcomes (1)

  • The change in proportion of subjects demonstrating improved tear film osmolarity

    Improved tear film osmolarity will be defined as an osmolarity reading of less than or equal to 308 mOsm/L or an inter-eye difference osmolarity reading of less than or equal to 8 mOsm/L.

    Baseline, Weeks 1, 2, 3 and 4

Secondary Outcomes (4)

  • The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9).

    Week 4

  • The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT).

    Week 4

  • The proportion of subjects demonstrating normal corneal fluorescein staining.

    Week 4

  • The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire.

    Week 4

Study Arms (1)

Lifitegrast 5% Ophthalmic Solution

EXPERIMENTAL

Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

Drug: Lifitegrast 5% Ophthalmic Solution

Interventions

Lifitegrast 5% Ophthalmic SolutionDRUG

Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

Lifitegrast 5% Ophthalmic Solution

Eligibility Criteria

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

You may qualify if:

  • Signs or symptoms of Dry Eye Disease
  • years or older
  • Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference \>=8 mOsm/mL)

You may not qualify if:

  • Active eye infection. Patients with blepharitis may be enrolled.
  • Any eye drop that was instilled within 2 hours of the Baseline eye exam
  • Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll.
  • History of ocular herpes simplex
  • Active episcleritis, scleritis, iritis or uveitis
  • Active keratitis secondary to any etiology other than dry eyes
  • History of refractive surgery (LASIK or PRK) or penetrating corneal transplant (PK)
  • Uses eye drops (ex. glaucoma or allergy drops) for indications other than dry eyes
  • Active allergic conjunctivitis
  • Current use of punctal plugs or anticipation of use during the study
  • Use of topical ophthalmic steroids within 14 days of the Baseline Visit or anticipated use during the study
  • Use of lifitegrast 5% or Restasis within 30 Days of the Baseline Visit.
  • Allergy to lifitegrast 5%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Ophthalmology

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrastOphthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Christopher Starr, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 16, 2019

Study Start

March 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)