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Effect of Lifitegrast 5% on Tear Film Markers

Primary Purpose

Dry Eye, Dry Eye Syndromes, Dry Eyes Chronic

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lifitegrast 5% Ophthalmic Solution
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dry Eye focused on measuring Dry Eye, Lifitegrast, Xiidra

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Weill Cornell Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifitegrast 5% Ophthalmic Solution

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
The proportion of subjects demonstrating normal corneal fluorescein staining.
Corneal staining will be assessed using the National Eye Institute Scale for corneal staining.
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.

Full Information

First Posted
May 10, 2019
Last Updated
February 10, 2021
Sponsor
Weill Medical College of Cornell University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT03952481
Brief Title
Effect of Lifitegrast 5% on Tear Film Markers
Official Title
Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID restrictions
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Novartis

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes, Dry Eyes Chronic
Keywords
Dry Eye, Lifitegrast, Xiidra

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifitegrast 5% Ophthalmic Solution
Arm Type
Experimental
Arm Description
Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Lifitegrast 5% Ophthalmic Solution
Intervention Description
Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.
Primary Outcome Measure Information:
Title
The change in proportion of subjects demonstrating improved tear film osmolarity
Description
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.
Time Frame
Baseline, Weeks 1, 2, 3 and 4
Secondary Outcome Measure Information:
Title
The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9).
Description
Normal MMP9 is determined by 2 blinded investigators who each independently read the test result as negative and who are in agreement.
Time Frame
Week 4
Title
The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT).
Description
Greater than 10 seconds is normal, 5 to 10 seconds is marginal, and less than 5 seconds is low.
Time Frame
Week 4
Title
The proportion of subjects demonstrating normal corneal fluorescein staining.
Description
Corneal staining will be assessed using the National Eye Institute Scale for corneal staining.
Time Frame
Week 4
Title
The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire.
Description
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.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Starr, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Ophthalmology
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Lifitegrast 5% on Tear Film Markers

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