Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

Bucci Laser Vision Institute

Status and phase: Withdrawn; Phase 4

Conditions: Dry Eye

Treatments: Drug: Lifitegrast 5% Ophthalmic Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04120987

IIR-USA-002133

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Lifitegrast

Active Comparator group

Description:

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

Treatment:

Drug: Lifitegrast 5% Ophthalmic Solution

Control

No Intervention group

Description:

No treatment