Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xiidra (Lifitegrast ophthalmic solution) 5%.
- Who it may be relevant to
- Registry conditions: Glaucoma, Ocular Surface Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Xiidra (Lifitegrast ophthalmic solution) 5%
FDA approved lifitegrast opthalmic solution eye drop
Primary outcome measures
- Change from baseline to week 12 in corneal fluorescein staining score [Time frame: From baseline to Week 12]
- Change from baseline to week 12 in eye dryness score (EDS) [Time frame: From baseline to Week 12]
- Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score [Time frame: From baseline to Week 12]
Secondary outcome measures (4)
- Change at intermediate week visits in corneal fluorescein staining score [Time frame: From baseline and at weeks 2, 6, and 12]
- Change at intermediate week visits in eye dryness score (EDS) [Time frame: From baseline and at weeks 2, 6, and 12]
- Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score [Time frame: 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 [Time frame: From baseline and at weeks 2, 6, and 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Doheny Eye Center UCLA — Fountain Valley
Identifiers
NCT: NCT04354545 · 19-000843