Back to resultsOcular Inflammation in Cataract Patients and Response to Treatment With Xiidra
Primary Purpose
Dry Eye
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lifitegrast 5% Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring cataract, lifitegrast, dry eye syndrome, ocular surface inflammation, hyperosmolarity, MMP-9
Eligibility Criteria
Inclusion Criteria:
- Positive for MMP-9 bilaterally as assessed by the Inflammadry assay
Exclusion Criteria:
- Negative Inflammadry assay in either eye
- Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation
- Ocular surface diseases that might confound the interpretation of the InflammaDry assay
Sites / Locations
- Bucci Laser Vision
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lifitegrast
Control
Arm Description
One drop of Lifitegrast Ophthalmic Solution 5% will be instilled into each eye twice daily (approximately 12 hours apart) using a single-use conainer.
No treatment
Outcomes
Primary Outcome Measures
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
Secondary Outcome Measures
Full Information
NCT ID
NCT04120987
First Posted
September 25, 2019
Last Updated
July 25, 2023
Sponsor
Bucci Laser Vision Institute
1. Study Identification
Unique Protocol Identification Number
NCT04120987
Brief Title
Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra
Official Title
The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
June 25, 2022 (Actual)
Study Completion Date
June 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bucci Laser Vision Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.
Detailed Description
Single-center, prospective, randomized, investigator-initiated study
250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay
Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra
The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
cataract, lifitegrast, dry eye syndrome, ocular surface inflammation, hyperosmolarity, MMP-9
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifitegrast
Arm Type
Active Comparator
Arm Description
One drop of Lifitegrast Ophthalmic Solution 5% will be instilled into each eye twice daily (approximately 12 hours apart) using a single-use conainer.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Drug
Intervention Name(s)
Lifitegrast 5% Ophthalmic Solution
Intervention Description
BID OU
Primary Outcome Measure Information:
Title
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
Description
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Positive for MMP-9 bilaterally as assessed by the Inflammadry assay
Exclusion Criteria:
Negative Inflammadry assay in either eye
Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation
Ocular surface diseases that might confound the interpretation of the InflammaDry assay
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank A Bucci, Jr., MD
Organizational Affiliation
Bucci Laser Vision
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucci Laser Vision
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra
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