Effect of Lifitegrast 5% on Tear Film Markers

Withdrawn before enrolling · Phase 4

Conditions studied: Dry Eye, Dry Eye Syndromes, Dry Eyes Chronic

In brief

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.

Key facts

Study ID

NCT03952481

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2021-03-01

Expected to finish

2021-12-31

Last updated by the study team

2021-02-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

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%

Where it is running

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

Full record on ClinicalTrials.gov

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