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NCT Number: NCT04354545

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension Ocular Surface Disease

Sex eligibility

All sexes

Study type

Observational

Primary location

Doheny Eye Center UCLA

Fountain Valley, California, 92708, United States

Location status: Recruiting

Location contact

Benjamin B Bert, MD

CONTACT

[email protected]

7149631444

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xiidra (Lifitegrast ophthalmic solution) 5%

Drug

FDA approved lifitegrast opthalmic solution eye drop

Other names: Lifitegrast ophthalmic solution, SAR-1118

Primary outcomes

  1. Change from baseline to week 12 in corneal fluorescein staining score

    Time frame: From baseline to Week 12

    Change in corneal fluorescein staining score

  2. Change from baseline to week 12 in eye dryness score (EDS)

    Time frame: From baseline to Week 12

    Change in eye dryness score (EDS)

  3. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin B Bert, MD

CONTACT

[email protected]

626-817-4701

Mayra Raygoza

CONTACT

[email protected]

16268174747 ext. 19093

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2020
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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