Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

Phase 4

Completed

• Conditions: Contact Lens; Contact Lens Discomfort; Contact Lens Dryness
• Interventions: Drug: Lifitegrast

• Registration Number: NCT03686878
• Lead Sponsor: EV Clinical Trials

Brief Summary

The most common reason for contact lens discontinuation is contact lens discomfort. The investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. This study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.

Detailed Description

Contact lens discontinuation is mostly associated with ocular discomfort. Most patients identifying dryness as the primary reason for contact lens discontinuation. Patients often resort to contact lens solutions, lubricating and/or rewetting drops to temporality improve their contact lens wearing experience. Clinicians often resort to changing contact lens designs, solutions and wearing modalities to improve comfort.

Contact lens discomfort is believed to be mediated by many factors including inflammation and very similar in clinical symptoms of dry eye disease and symptoms of dryness.

Lifitegrast 5.0% ophthalmic solution is an FDA approved solution for the management of signs and symptoms of dryness of dry eye disease. Studies have shown lifitegrast 5% ophthalmic solution may work by blocking the interaction between ICAM-1 and LFA-1 leading to a decrease in activation and recruitment of T-cells, an initial step in inflammation.

The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients for signs (https://www.xiidra-ecp.com/efficacy-treating-signs) and symptoms (https://www.xiidra-ecp.com/efficacy-symptom-improvement).

The purpose of this open label, interventional study is to examine the effect of lifitegrast 5% ophthalmic solution in contact lens wearing experience by using the CLDEQ-8.

Study Timeline

• Study Start: 2016-12-16
• Primary Completion: 2017-07-14
• Study Completion: 2017-07-14
• Status Verified: 2018-09
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-25
• Last Update Submitted: 2018-09-26
• Study First Posted: 2018-09-27
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Agree with study protocol
2. Provide Informed Consent
3. Age 21 or over
4. Previous 10 months history of self-assessed comfortable wear samfilcon A contact lenses

Exclusion Criteria

1. Unable or unwilling to comply with study protocol

2. Unable of unwilling to provide Informed consent

3. Self-reported symptomatic intolerance of contact lenses

4. History of an active anterior segment, eyelids, eyelashes, corneal or conjunctival pathology, ongoing ocular infection, inflammation or any other ocular problem that would require management with additional topical ophthalmic medications.

5. Have had a history of corneal surgery (corneal transplants, LASIK, PRK).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Lifitegrast	Lifitegrast 5% ophthalmic solution group

Primary Outcome Measures

Name	Time	Method
Change in CLDEQ-8 scores as reported by study participants	baseline to week 8	measured changes in CLDEQ-8 scores as reported by study participants
Lisamine (corneal, conjunctiva) staining scores	baseline to week 8	Lisamine score using the Oxford-Schema scoring

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	Baseline to week 8	Best corrected visual acuity measured by Snellen chart

Trial Locations

Locations (1)

Eye & Vision; 🇺🇸 Richardson, Texas, United States