Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

Glaucoma Clinical Trial

Official title:

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04354545
• Other study ID #: 19-000843
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2022
• Source: University of California, Los Angeles
• Contact: Benjamin B Bert, MD
• Phone: 626-817-4701
• Email: BBert[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Ocular Surface Disease

Intervention

Drug:
• Xiidra (Lifitegrast ophthalmic solution) 5%
FDA approved lifitegrast opthalmic solution eye drop

Locations

Country	Name	City	State
United States	Doheny Eye Center UCLA	Fountain Valley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 12 in corneal fluorescein staining score	Change in corneal fluorescein staining score	From baseline to Week 12
Primary	Change from baseline to week 12 in eye dryness score (EDS)	Change in eye dryness score (EDS)	From baseline to Week 12
Primary	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	Change at intermediate week visits in corneal fluorescein staining score	Change in corneal fluorescein staining score	From baseline and at weeks 2, 6, and 12
Secondary	Change at intermediate week visits in eye dryness score (EDS)	Change in eye dryness score (EDS)	From baseline and at weeks 2, 6, and 12
Secondary	Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score	Change in ocular surface disease index (OSDI) questionnaire score	From baseline and at weeks 2, 6, and 12
Secondary	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	From baseline and at weeks 2, 6, and 12