Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

Phase 4

Withdrawn

• Conditions: Dry Eye
• Interventions: Drug: Lifitegrast 5% Ophthalmic Solution

• Registration Number: NCT04120987
• Lead Sponsor: Bucci Laser Vision Institute

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.

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2021-05-31
• Primary Completion: 2022-06-25
• Study Completion: 2022-06-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifitegrast	Lifitegrast 5% Ophthalmic Solution	One drop of Lifitegrast Ophthalmic Solution 5% will be instilled into each eye twice daily (approximately 12 hours apart) using a single-use conainer.

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Bucci Laser Vision; 🇺🇸 Wilkes-Barre, Pennsylvania, United States