Effect of Lifitegrast 5% on Tear Film Markers

NCT ID: NCT03952481

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-31

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.

Conditions

Dry Eye; Dry Eye Syndromes; Dry Eyes Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lifitegrast 5% Ophthalmic Solution

Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

Group Type: EXPERIMENTAL

Lifitegrast 5% Ophthalmic Solution

Intervention Type: DRUG

Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

Interventions

Lifitegrast 5% Ophthalmic Solution

Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

Intervention Type: DRUG

Eligibility 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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Starr, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Ophthalmology

New York, New York, United States

Countries

United States

Other Identifiers

1804019156

Identifier Type: -

Identifier Source: org_study_id