Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

NCT ID: NCT04354545

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Glaucoma Ocular Surface Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Xiidra (Lifitegrast ophthalmic solution) 5%

Intervention Type DRUG

FDA approved lifitegrast opthalmic solution eye drop

Interventions

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Xiidra (Lifitegrast ophthalmic solution) 5%

FDA approved lifitegrast opthalmic solution eye drop

Intervention Type DRUG

Other Intervention Names

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Lifitegrast ophthalmic solution SAR-1118

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Benjamin B. Bert, MD

Health Sciences Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Doheny Eye Center UCLA

Fountain Valley, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Benjamin B Bert, MD

Role: CONTACT

626-817-4701

Connie Zhen

Role: CONTACT

626-817-4722

Facility Contacts

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Benjamin B Bert, MD

Role: primary

714-963-1444

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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19-000843

Identifier Type: -

Identifier Source: org_study_id

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