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NCT04120987 Clinical Trial

Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04120987
Other study ID # IIR-USA-002133
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date May 31, 2021
Est. completion date June 25, 2022

Study information
Verified date July 2023
Source Bucci Laser Vision Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 25, 2022
Est. primary completion date June 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lifitegrast 5% Ophthalmic Solution
BID OU

Locations
Country Name City State
United States Bucci Laser Vision Wilkes-Barre Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Bucci Laser Vision Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 12 weeks
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