Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Glaucoma patients suffering from ocular surface discomfort
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Xiidra (Lifitegrast ophthalmic solution) 5%
DrugFDA approved lifitegrast opthalmic solution eye drop
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Group 11 intervention
Trial outcomes
Primary outcomes
1
Change from baseline to week 12 in corneal fluorescein staining score
Change in corneal fluorescein staining score
Time frame
From baseline to Week 122
Change from baseline to week 12 in eye dryness score (EDS)
Change in eye dryness score (EDS)
Time frame
From baseline to Week 123
Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score
Change in ocular surface disease index (OSDI) questionnaire score
Time frame
From baseline to Week 12Secondary outcomes
1
Change at intermediate week visits in corneal fluorescein staining score
Change in corneal fluorescein staining score
Time frame
From baseline and at weeks 2, 6, and 122
Change at intermediate week visits in eye dryness score (EDS)
Change in eye dryness score (EDS)
Time frame
From baseline and at weeks 2, 6, and 123
Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score
Change in ocular surface disease index (OSDI) questionnaire score
Time frame
From baseline and at weeks 2, 6, and 124
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
Time frame
From baseline and at weeks 2, 6, and 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Bausch & Lomb Incorporated
Collaborator
Source ClinicalTrials.gov