Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2022-06-25

Brief Summary

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

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Detailed Description

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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

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lifitegrast 5% Ophthalmic Solution

Intervention Type DRUG

BID OU

Control

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifitegrast 5% Ophthalmic Solution

BID OU

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes