Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

Study Overview
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Brief Summary
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To evaluate glaucoma patients' response to treatment with Xiidra, an FDA-approved drug for ocular surface discomfort, which will be prescribed as standard of care treatment.

Detailed Description
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To assess glaucoma patients' response to treatment with Xiidra (Lifitegrast ophthalmic solution) 5% for ocular surface discomfort caused, in part, by topical glaucoma antihypertensive medications.

Official Title
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Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

Conditions
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Glaucoma, Ocular Surface Disease

Intervention / Treatment
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* Drug: Xiidra (Lifitegrast ophthalmic solution) 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently using one or more topical glaucoma antihypertensives Self-described symptoms of ocular surface discomfort Xiidra is being prescribed as part of the subject's standard care Exclusion Criteria: History of glaucoma filtration surgery, history of ocular surface surgery (pterygium, conjunctivoplasty, etc.), current use of topical cyclosporine current use of topical steroids incisional ocular surgery within 6 months
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Xiidra (Lifitegrast ophthalmic solution) 5% applied to both eye (OU) for 12 weeks | Drug: Xiidra (Lifitegrast ophthalmic solution) 5%<br>* FDA approved lifitegrast opthalmic solution eye drop<br>* Other names: SAR-1118;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 12 in corneal fluorescein staining score | Change in corneal fluorescein staining score | From baseline to Week 12 | 
| Change from baseline to week 12 in eye dryness score (EDS) | Change in eye dryness score (EDS) | From baseline to Week 12 | 
| Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score | Change in ocular surface disease index (OSDI) questionnaire score | From baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change at intermediate week visits in corneal fluorescein staining score | Change in corneal fluorescein staining score | From baseline and at weeks 2, 6, and 12 | 
| Change at intermediate week visits in eye dryness score (EDS) | Change in eye dryness score (EDS) | From baseline and at weeks 2, 6, and 12 | 
| Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score | Change in ocular surface disease index (OSDI) questionnaire score | From baseline and at weeks 2, 6, and 12 | 
| Changes in the subcategories of ocular surface disease index (OSDI) questionnaire score at intermediate week visits | Change in subcategory scores of ocular surface disease index (OSDI) questionnaire | From baseline and at weeks 2, 6, and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, xiidra™, ocular surface discomfort