Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

Recruiting

• Conditions: Glaucoma; Ocular Surface Disease
• Interventions: Drug: Xiidra (Lifitegrast ophthalmic solution) 5%

• Registration Number: NCT04354545
• Lead Sponsor: University of California, Los Angeles

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.

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 Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Study Start: 2021-04-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Xiidra (Lifitegrast ophthalmic solution) 5%	Xiidra (Lifitegrast ophthalmic solution) 5% applied to both eye (OU) for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 12 in corneal fluorescein staining score	From baseline to Week 12	Change in corneal fluorescein staining score
Change from baseline to week 12 in eye dryness score (EDS)	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	From baseline to Week 12	Change in ocular surface disease index (OSDI) questionnaire score

Secondary Outcome Measures

Name	Time	Method
Change at intermediate week visits in corneal fluorescein staining score	From baseline and at weeks 2, 6, and 12	Change in corneal fluorescein staining score
Change at intermediate week visits in eye dryness score (EDS)	From baseline and at weeks 2, 6, and 12	Change in eye dryness score (EDS)
Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score	From baseline and at weeks 2, 6, and 12	Change in ocular surface disease index (OSDI) questionnaire score
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	Change in subcategory scores of ocular surface disease index (OSDI) questionnaire

Trial Locations

Locations (1)

Doheny Eye Center UCLA; 🇺🇸 Fountain Valley, California, United States