Effect of Lifitegrast 5% on Tear Film Markers

Weill Cornell Medicine (WCM)

Status and phase

Withdrawn

Phase 4

Conditions

Dry Eyes Chronic

Dry Eye

Dry Eye Syndromes

Treatments

Drug: Lifitegrast 5% Ophthalmic Solution

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03952481

1804019156

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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%