Glaucoma, Ocular Surface Disease
Conditions
Keywords
glaucoma, xiidra™, ocular surface discomfort
Brief summary
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
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.
Interventions
DRUGXiidra (Lifitegrast ophthalmic solution) 5%
FDA approved lifitegrast opthalmic solution eye drop
Sponsors
University of California, Los Angeles
Bausch & Lomb Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 12 in corneal fluorescein staining score | From baseline to Week 12 | Change in corneal fluorescein staining score |
| Change from baseline to week 12 in eye dryness score (EDS) | From baseline to Week 12 | Change in eye dryness score (EDS) |
| Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score | From baseline to Week 12 | Change in ocular surface disease index (OSDI) questionnaire score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change at intermediate week visits in corneal fluorescein staining score | From baseline and at weeks 2, 6, and 12 | Change in corneal fluorescein staining score |
| Change at intermediate week visits in eye dryness score (EDS) | From baseline and at weeks 2, 6, and 12 | Change in eye dryness score (EDS) |
| Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score | From baseline and at weeks 2, 6, and 12 | Change in ocular surface disease index (OSDI) questionnaire score |
| Changes in the subcategories of ocular surface disease index (OSDI) questionnaire score at intermediate week visits | From baseline and at weeks 2, 6, and 12 | Change in subcategory scores of ocular surface disease index (OSDI) questionnaire |
Countries
United States
Contacts
CONTACTBenjamin B Bert, MD
CONTACTMayra Raygoza
Outcome results
None listed