Effect of Lifitegrast 5% on Tear Film Markers

Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye; Dry Eye Syndromes; Dry Eyes Chronic
• Intervention / Treatment: Drug: Lifitegrast 5% Ophthalmic Solution

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signs or symptoms of Dry Eye Disease
• 18 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)

Exclusion Criteria:

• 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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifitegrast 5% Ophthalmic Solution; Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.	Drug: Lifitegrast 5% Ophthalmic Solution; Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9).	Normal MMP9 is determined by 2 blinded investigators who each independently read the test result as negative and who are in agreement.	Week 4
The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT).	Greater than 10 seconds is normal, 5 to 10 seconds is marginal, and less than 5 seconds is low.	Week 4
The proportion of subjects demonstrating normal corneal fluorescein staining.	Corneal staining will be assessed using the National Eye Institute Scale for corneal staining.	Week 4
The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire.	A modified SANDE Questionnaire uses a visual analogue scale at the Baseline Visit to measure the frequency and severity of subject's dry eyes symptoms. Subsequent visit Questionnaires will use a visual analogue scale to measure the change in symptoms compare to the results of the prior visit.	Week 4

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Novartis
• Investigators: Principal Investigator: Christopher Starr, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye; Lifitegrast; Xiidra
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: 1804019156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No