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Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354545
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : July 13, 2021
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Benjamin B. Bert, MD, 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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : April 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Lifitegrast

Group/Cohort 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




Primary Outcome Measures :
  1. Change from baseline to week 12 in corneal fluorescein staining score [ Time Frame: From baseline to Week 12 ]
    Change in corneal fluorescein staining score

  2. Change from baseline to week 12 in eye dryness score (EDS) [ Time Frame: From baseline to Week 12 ]
    Change in eye dryness score (EDS)

  3. Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score [ Time Frame: From baseline to Week 12 ]
    Change in ocular surface disease index (OSDI) questionnaire score


Secondary Outcome Measures :
  1. Change at intermediate week visits in corneal fluorescein staining score [ Time Frame: From baseline and at weeks 2, 6, and 12 ]
    Change in corneal fluorescein staining score

  2. Change at intermediate week visits in eye dryness score (EDS) [ Time Frame: From baseline and at weeks 2, 6, and 12 ]
    Change in eye dryness score (EDS)

  3. Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score [ Time Frame: From baseline and at weeks 2, 6, and 12 ]
    Change in ocular surface disease index (OSDI) questionnaire score

  4. Changes in the subcategories of ocular surface disease index (OSDI) questionnaire score at intermediate week visits [ Time Frame: From baseline and at weeks 2, 6, and 12 ]
    Change in subcategory scores of ocular surface disease index (OSDI) questionnaire



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Glaucoma patients suffering from ocular surface discomfort
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354545


Contacts
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Contact: Benjamin B Bert, MD 626-817-4701 BBert@mednet.ucla.edu
Contact: Connie Zhen 626-817-4722 CZhen@mednet.ucla.edu

Locations
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United States, California
Doheny Eye Center UCLA Recruiting
Fountain Valley, California, United States, 92708
Contact: Benjamin B Bert, MD    714-963-1444    CZhen@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Novartis
  Study Documents (Full-Text)

Documents provided by Benjamin B. Bert, MD, University of California, Los Angeles:
Informed Consent Form  [PDF] March 4, 2020

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Responsible Party: Benjamin B. Bert, MD, Health Sciences Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04354545    
Other Study ID Numbers: 19-000843
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin B. Bert, MD, University of California, Los Angeles:
glaucoma
xiidra™
ocular surface discomfort
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Lifitegrast
Ophthalmic Solutions