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WithdrawnNCT04120987Updated Jul 27, 2023

Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

A Phase 4 interventional study of Lifitegrast 5% Ophthalmic Solution in Dry Eye, sponsored by Bucci Laser Vision Institute. Withdrawn at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Bucci Laser Vision Institute · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Administrative
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dry Eye

Keywords

  • cataract
  • lifitegrast
  • dry eye syndrome
  • ocular surface inflammation
  • hyperosmolarity
  • MMP-9
03

In context

Dry Eye Syndromes

1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.

Browse Dry Eye Syndromes studies →

Lead sponsor

Bucci Laser Vision Institute is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Positive for MMP-9 bilaterally as assessed by the Inflammadry assay

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    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.

    Drug: Lifitegrast 5% Ophthalmic Solution

  • No intervention
    Control

    No treatment

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    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

07

Study locations

1 site
  • Bucci Laser Vision
    Wilkes-Barre, Pennsylvania 18702, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04120987
Lead sponsor
Bucci Laser Vision Institute
Responsible party
Sponsor
First posted
Oct 9, 2019
Start date
May 31, 2021
Primary completion
Jun 25, 2022
Completion
Jun 25, 2022
Last update
Jul 27, 2023

Study contacts

Frank A Bucci, Jr., MD
principal investigator · Bucci Laser Vision

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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