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Effect of Lifitegrast 5% on Tear Film Markers

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ClinicalTrials.gov Identifier: NCT03952481
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Dry Eye Dry Eye Syndromes Dry Eyes Chronic Drug: Lifitegrast 5% Ophthalmic Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study
Estimated Study Start Date : September 20, 2019
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Lifitegrast

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.




Primary Outcome Measures :
  1. The change in proportion of subjects demonstrating improved tear film osmolarity [ Time Frame: Baseline, Weeks 1, 2, 3 and 4 ]
    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 :
  1. The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9). [ Time Frame: Week 4 ]
    Normal MMP9 is determined by 2 blinded investigators who each independently read the test result as negative and who are in agreement.

  2. The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT). [ Time Frame: Week 4 ]
    Greater than 10 seconds is normal, 5 to 10 seconds is marginal, and less than 5 seconds is low.

  3. The proportion of subjects demonstrating normal corneal fluorescein staining. [ Time Frame: Week 4 ]
    Corneal staining will be assessed using the National Eye Institute Scale for corneal staining.

  4. The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire. [ Time Frame: Week 4 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952481


Contacts
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Contact: Susan Herder, BA, PA-C 646-962-4118 herders@med.cornell.edu

Sponsors and Collaborators
Weill Medical College of Cornell University
Novartis
Investigators
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Principal Investigator: Christopher Starr, MD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03952481     History of Changes
Other Study ID Numbers: 1804019156
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Weill Medical College of Cornell University:
Dry Eye
Lifitegrast
Xiidra
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lifitegrast
Ophthalmic Solutions
Pharmaceutical Solutions