Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

Study Overview
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Brief Summary
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This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).

Official Title
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Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Lifitegrast 5% Ophthalmic Solution
* Other: Lifitegrast Ophthalmic Solution Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must read, understand and sign the Statement of Informed Consent Subjects must be at least 18 years of age Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule Habitual contact lenses must have a suitable fit as determined by the investigator Subjects must report a history of dry eye symptoms, for which they have used rewetting drops or Artificial Tears (ATs) in the past 30 days Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study Subjects must have a score of 12 or higher on the CLDEQ at baseline Subjects must have at least 2 of the following signs of dry eye disease: High tear osmolarity > 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes Any corneal staining Any bulbar conjunctival staining Low TBUT (tear break up time) (<10s) Schirmer <10mm in either eye Subjects must be able to read at least half of the 20/25 (via entrance Snellen visual acuity) or better in each eye in their current contact lens prescription. Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study. Exclusion Criteria: Currently pregnant or breastfeeding by self-report Allergy to lifitegrast ophthalmic solution 5% (Xiidra) Habitual extended wear contact lens schedule Any active ocular disease that may affect the ocular surface other than dry eye (significant blepharitis, allergic conjunctivitis, lagophthalmos, chalazia, hordeolum etc.) Any meibomian gland dysfunction, blepharitis, corneal neovascularization or papillary conjunctivitis that is grade 3 or higher using the Efron Grading Scale. Excessive corneal staining, that in the opinion of the investigator, is a contraindication to contact lens use. History of ocular surgery Any active ocular infection Use of any topical ophthalmic medications other than artificial tears or rewetting drops Inability to perform necessary visual function assessments Punctal plug insertion in the last 3 months, or presence of punctal plugs at the time of the exam.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lifitegrast Ophthalmic Solution Vehicle<br> | Other: Lifitegrast Ophthalmic Solution Vehicle<br>* Dosed twice a day for 8 weeks<br>|
| Experimental: Lifitegrast Ophthalmic Solution 5%<br> | Drug: Lifitegrast 5% Ophthalmic Solution<br>* Dosed twice a day for 8 weeks<br>* Other names: Xiidra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in contact lens wearers | Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) as compared to subjects using lifitegrast ophthalmic solution vehicle | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tear osmolarity | Change in tear osmolarity at 8 weeks in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle | 8 weeks | 
| Forced choice questionnaire | Forced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study | 8 weeks | 
| Change in total score on the CLDEQ- 8 at 2 weeks and 4 weeks | Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle | 2 weeks and 4 weeks | 
| Trends in responses to individual questions on the CLDEQ-8 | Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle | 2 weeks, 4 weeks, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Soft Contact Lenses