Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra

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

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Lifitegrast 5% Ophthalmic Solution

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No treatment
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.	Drug: Lifitegrast 5% Ophthalmic Solution; BID OU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bucci Laser Vision Institute
• Investigators: Principal Investigator: Frank A Bucci, Jr., MD, Bucci Laser Vision

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Actual): June 25, 2022
• Study Completion (Actual): June 25, 2022

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cataract; dry eye syndrome; lifitegrast; ocular surface inflammation; hyperosmolarity; MMP-9
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Lacrimal Apparatus Diseases; Inflammation; Cataract; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: IIR-USA-002133

Drug and device information, study documents

• 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