Overview

Effect of Lifitegrast 5% on Tear Film Markers

Status:
Withdrawn
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Novartis
Shire Human Genetic Therapies, Inc.
Treatments:
Lifitegrast
Ophthalmic Solutions
Pharmaceutical Solutions
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%