- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354545
Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
October 31, 2022 updated by: Benjamin B. Bert, MD, University of California, Los Angeles
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.
Study Overview
Status
Recruiting
Conditions
Intervention / 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.
Study Type
Observational
Enrollment (Anticipated)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin B Bert, MD
- Phone Number: 626-817-4701
- Email: BBert@mednet.ucla.edu
Study Contact Backup
- Name: Connie Zhen
- Phone Number: 626-817-4722
- Email: CZhen@mednet.ucla.edu
Study Locations
-
-
California
-
Fountain Valley, California, United States, 92708
- Recruiting
- Doheny Eye Center UCLA
-
Contact:
- Benjamin B Bert, MD
- Phone Number: 714-963-1444
- Email: CZhen@mednet.ucla.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Glaucoma patients suffering from ocular surface discomfort
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Xiidra (Lifitegrast ophthalmic solution) 5% applied to both eye (OU) for 12 weeks
|
FDA approved lifitegrast opthalmic solution eye drop
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to week 12 in corneal fluorescein staining score
Time Frame: From baseline to Week 12
|
Change in corneal fluorescein staining score
|
From baseline to Week 12
|
Change from baseline to week 12 in eye dryness score (EDS)
Time Frame: From baseline to Week 12
|
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
Time Frame: From baseline to Week 12
|
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
Time Frame: From baseline and at weeks 2, 6, and 12
|
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)
Time Frame: From baseline and at weeks 2, 6, and 12
|
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
Time Frame: From baseline and at weeks 2, 6, and 12
|
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
Time Frame: From baseline and at weeks 2, 6, and 12
|
Change in subcategory scores of ocular surface disease index (OSDI) questionnaire
|
From baseline and at weeks 2, 6, and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
April 15, 2020
First Submitted That Met QC Criteria
April 17, 2020
First Posted (Actual)
April 21, 2020
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-000843
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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