Effect of Lifitegrast 5% on Tear Film Markers

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03952481
• Other study ID #: 1804019156
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Dry Eyes Chronic
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lifitegrast 5% Ophthalmic Solution
Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

Locations

Country	Name	City	State
United States	Weill Cornell Ophthalmology	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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