Discomfort with contact lens wear is the biggest reason why people stop wearing contact lenses. The investigators believe that inflammation is one of the causes of discomfort, and by blocking the inflammation using lifitegrast, the investigators may be able to relieve some of that discomfort. This study will enroll 50 subjects with contact lens discomfort and will receive lifitegrast to use over a period of approximately 3 months.
The most common reason for contact lens drop out is ocular discomfort, with patients identifying dryness as the major reason. Currently, many patients with contact lens dry eye (CLDE) utilize rewetting drops to relieve their symptoms. The problem with rewetting drops is that they fail as they are transient, and do not address the inflammatory component of contact lens discomfort. Lifitegrast 5.0% ophthalmic solution was approved and is now marketed as Xiidra, for the treatment of signs and symptoms of dry eye disease. Lifitegrast works by reducing inflammation, which suggests that it may be effective in patients with contact lens dry eye. More specifically, lifitegrast may work by blocking the interaction between ICAM-1 and LFA-1, which leads to a decrease in the activation and recruitment of T-cells, and a decrease in pro-inflammatory cytokines. The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients. Each study assessed the effects of Xiidra on symptoms using an Eye Dryness Score (EDS), which is a visual analogue ranging from 0 (no discomfort) to 100 (maximal discomfort). In two of those studies, lifitegrast was shown to improve symptom relief at weeks 2, 6, and 12 compared to the placebo (https://www.xiidra-ecp.com/efficacy-symptom-improvement). Each of the four clinical trials mentioned above also assessed clinical signs of dry eye disease, with a particular focus on inferior corneal staining graded on 0.5 unit increments on a 0 (no staining) to 4 scale (coalescent). In three of the four clinical trials, lifitegrast reduced inferior corneal staining by week 12, compared to placebo (https://www.xiidra-ecp.com/efficacy-treating-signs). Contact lens dry eye is mediated by significant symptoms of ocular surface dryness, in addition to similar clinical signs of dry eye disease such as corneal staining and inflammation. Thus, the purpose of this interventional study is to examine the effect of lifitegrast ophthalmic solution in subjects with contact lens dry eye.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Eye drop
University of Alabama at Birmingham
Birmingham, Alabama, United States
Number of hours related to comfort in wearing contact lenses.
The amount of comfortable lens wear time averaged over the 12th week of lens wear as reported with participant diary.
Time frame: Baseline to Week 12.
Number of hours related to comfort in wearing contact lenses.
The amount of comfortable lens wear time averaged over the 2nd week of lens wear as reported with participant diary.
Time frame: Baseline to Week 2.
Number of hours related to comfort in wearing contact lenses.
The amount of comfortable lens wear time averaged over the 6th week of lens wear as reported with participant diary.
Time frame: Baseline to Week 6.
Number of hours related to total contact lens wear.
The amount of total lens wear time averaged over the 2nd week of lens wear as reported with participant diary.
Time frame: Baseline to Week 2.
Number of hours related to total contact lens wear.
The amount of total lens wear time averaged over the 6th week of lens wear as reported with participant diary.
Time frame: Baseline to Week 6.
Number of hours related to total contact lens wear
The amount of total lens wear time averaged over the 12th week of lens wear as reported with participant diary.
Time frame: Baseline to Week 12
Number of hours of overall eye dryness in the morning.
The amount of overall eye dryness experienced in the morning, averaged over the 2nd week of lens wear as reported with participant diary.
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Time frame: Baseline to Week 2.
Number of hours of overall eye dryness in the morning.
The amount of overall eye dryness experienced in the morning, averaged over the 6th week of lens wear as reported with participant diary.
Time frame: Baseline to Week 6th.
Number of hours of overall eye dryness in the morning.
The amount of overall eye dryness experienced in the morning, averaged over the 12th week of lens wear as reported with participant diary.
Time frame: Baseline to Week 12th.
Number of hours of overall eye dryness in the evening.
The amount of overall eye dryness experienced in the evening, averaged over the 2nd week of lens wear as reported with participant diary.
Time frame: Baseline to Week 2.
Number of hours of overall eye dryness in the evening
The amount of overall eye dryness experienced in the evening, averaged over the 6th week of lens wear as reported with participant diary
Time frame: Baseline to Week 6
Number of hours of overall eye dryness in the evening.
The amount of overall eye dryness experienced in the evening, averaged over the 12th week of lens wear as reported with participant diary.
Time frame: Baseline to Week 12.
Change in Contact Lens Dry Eye diagnosis.
The participant diagnosis is made using the Contact Lens Dry Eye Questionnaire at Week 2.
Time frame: Baseline to Week 2.
Change in Contact Lens Dry Eye diagnosis.
The participant diagnosis is made using the Contact Lens Dry Eye Questionnaire at Week 6.
Time frame: Baseline to Week 6.
Change in Contact Lens Dry Eye diagnosis.
The participant diagnosis is made using the Contact Lens Dry Eye Questionnaire at Week 12.
Time frame: Baseline to Week 12.