Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

March 11, 2026 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 (Estimated)

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

Study Contact Backup

Study Locations

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

Yes

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
Drug: Xiidra (Lifitegrast ophthalmic solution) 5%
FDA approved lifitegrast opthalmic solution eye drop
Other Names:
  • Lifitegrast ophthalmic solution
  • SAR-1118

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.

Sponsor

University of California, Los Angeles

Collaborators

Bausch & Lomb Incorporated

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 (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

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)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

December 1, 2025

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.

Clinical Trials on Glaucoma

Clinical Trials on Xiidra (Lifitegrast ophthalmic solution) 5%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe