NCT04120987

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2022

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

September 25, 2019

Last Update Submit

July 25, 2023

Conditions

Dry Eye

Keywords

cataractlifitegrastdry eye syndromeocular surface inflammationhyperosmolarityMMP-9

Outcome Measures

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

    12 weeks

Study Arms (2)

Lifitegrast

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

No treatment

Interventions

Lifitegrast 5% Ophthalmic SolutionDRUG

BID OU

Lifitegrast

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesCataract

Interventions

lifitegrastOphthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Frank A Bucci, Jr., MD

    Bucci Laser Vision

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

October 9, 2019

Study Start

May 31, 2021

Primary Completion

June 25, 2022

Study Completion

June 25, 2022

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

US(1)