Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT04354545

Collaborator

Novartis (Industry)

Enrollment

Location

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Surface Disease	Drug: Xiidra (Lifitegrast ophthalmic solution) 5%

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 Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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