Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

Phase 4WithdrawnNCT04120987

Bucci Laser Vision Institute

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Dry Eye

Interventions

Lifitegrast 5% Ophthalmic SolutionDRUG

BID OU

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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