GlaucomaNCT04354545
Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
An observational study of Glaucoma and Ocular Surface Disease, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Ocular Surface Disease
- What is being tested?
- Xiidra (Lifitegrast ophthalmic solution) 5%
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Glaucoma patients suffering from ocular surface discomfort
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Doheny Eye Center UCLA
Fountain Valley, California, 92708
Benjamin B Bert, MD, 7149631444, JanettMendez@mednet.ucla.edu
About this study
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.
Read the 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.
- Conditions
- Glaucoma, Ocular Surface Disease
- Being tested
- Xiidra (Lifitegrast ophthalmic solution) 5%
- Keywords
- glaucoma, xiidra™, ocular surface discomfort
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiidra (Lifitegrast ophthalmic solution) 5%Drug
Also called Lifitegrast ophthalmic solution, SAR-1118
FDA approved lifitegrast opthalmic solution eye drop
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Xiidra (Lifitegrast ophthalmic solution) 5% applied to both eye (OU) for 12 weeks Receives: Drug: Xiidra (Lifitegrast ophthalmic solution) 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 12 in corneal fluorescein staining score
Change in corneal fluorescein staining score
Measured: From baseline to Week 12
Change from baseline to week 12 in eye dryness score (EDS)
Change in eye dryness score (EDS)
Measured: 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
Measured: From baseline to Week 12
Secondary outcomes (4)
Change at intermediate week visits in corneal fluorescein staining score
Change in corneal fluorescein staining score
Measured: 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)
Measured: 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
Measured: 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
Measured: From baseline and at weeks 2, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Apr 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Benjamin B. Bert, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354545
- Sponsor's protocol ID
- 19-000843
- Status last verified
- Dec 2025
- First submitted
- 15 Apr 2020
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
- ClinicalTrials.gov ID
- NCT04354545
- Acronym / sponsor ID
- 19-000843
- Conditions
- Glaucoma, Ocular Surface Disease
- Keywords
- glaucoma, xiidra™, ocular surface discomfort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Xiidra (Lifitegrast ophthalmic solution) 5%Xiidra (Lifitegrast ophthalmic solution) 5% applied to both eye (OU) for 12 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Glaucoma patients suffering from ocular surface discomfort
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiidra (Lifitegrast ophthalmic solution) 5%Also: Lifitegrast ophthalmic solution, SAR-1118FDA approved lifitegrast opthalmic solution eye drop | Drug | Group 1 |
Primary outcome
Change from baseline to week 12 in corneal fluorescein staining score
Time frame: From baseline to Week 12
Change in corneal fluorescein staining score
Change from baseline to week 12 in eye dryness score (EDS)
Time frame: 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
Time frame: From baseline to Week 12
Change in ocular surface disease index (OSDI) questionnaire score
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Ocular Surface Disease, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin B Bert, MD (626-817-4701, BBert@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 12 in corneal fluorescein staining score (time frame: From baseline to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.