NCT04120987

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bucci Laser Vision Institute · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Lifitegrast 5% Ophthalmic Solution	BID OU

Timeline

• Start date: 2021-05-31
• Primary completion: 2022-06-25
• Completion: 2022-06-25
• First posted: 2019-10-09
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study