Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Lifitegrast 5% Ophthalmic Solution in Contact Lens Discomfort

Conditions
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Contact Lens, Contact Lens Discomfort, Contact Lens Dryness

Intervention / Treatment
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* Drug: Lifitegrast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree with study protocol Provide Informed Consent Age 21 or over Previous 10 months history of self-assessed comfortable wear samfilcon A contact lenses Exclusion Criteria: Unable or unwilling to comply with study protocol Unable of unwilling to provide Informed consent Self-reported symptomatic intolerance of contact lenses 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. Have had a history of corneal surgery (corneal transplants, LASIK, PRK). -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Lifitegrast 5% ophthalmic solution group | Drug: Lifitegrast<br>* Lifitegrast used twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Best corrected visual acuity measured by Snellen chart | Baseline to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratoconjunctivitis Sicca, Dry Eye Disease, Eye Dryness