Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 25, 2020

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.

Interventions

  • Drug: Lifitegrast 5% Ophthalmic Solution
    • BID OU

Arms, Groups and Cohorts

  • Active Comparator: Lifitegrast
    • 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 Intervention: Control
    • No treatment

Clinical Trial Outcome Measures

Primary 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
    • Time Frame: 12 weeks
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bucci Laser Vision Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Frank A Bucci, Jr., MD, Principal Investigator, Bucci Laser Vision

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