Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

NCT04354545 | Recruiting FDA Drug

• 1 other identifier: 19-000843
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma; Ocular Surface Disease

Keywords

glaucoma; xiidra™; ocular surface discomfort

Outcome Measures

Primary Outcomes (3)

• Change from baseline to week 12 in corneal fluorescein staining score

  Change in corneal fluorescein staining score

  From baseline to Week 12

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

  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

  Change in ocular surface disease index (OSDI) questionnaire score

  From baseline to Week 12

Secondary Outcomes (4)

• Change at intermediate week visits in corneal fluorescein staining score

  From baseline and at weeks 2, 6, and 12

• Change at intermediate week visits 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

  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

  From baseline and at weeks 2, 6, and 12

Study Arms (1)

Group 1

Xiidra (Lifitegrast ophthalmic solution) 5% applied to both eye (OU) for 12 weeks

Drug: Xiidra (Lifitegrast ophthalmic solution) 5%

Interventions

Xiidra (Lifitegrast ophthalmic solution) 5% DRUG

FDA approved lifitegrast opthalmic solution eye drop

Also known as: Lifitegrast ophthalmic solution, SAR-1118

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glaucoma patients suffering from ocular surface discomfort

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Doheny Eye Center UCLA

Fountain Valley, California, 92708, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Benjamin B Bert, MD

CONTACT

626-817-4701; BBert@mednet.ucla.edu

Mayra Raygoza

CONTACT

16268174747; Mraygoza@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Assistant Professor

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-12

Locations

US (1)