NCT03866629

The Effect Of Lifitegrast On Refractive Accuracy And Symptoms In Dry Eye Patients Undergoing Cataract Surgery

The Effect of Lifitegrast On Refractive Accuracy And Symptoms In Dry Eye Patients Undergoing Cataract Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: MDbackline, LLC · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

To determine if Xiidra® lifitegrast plays a role in the refractive accuracy when administered to patients preoperatively who are scheduled for cataract surgery and have a tear break up time (TBUT) ≤ 10 seconds and central corneal staining as defined by the Oxford scale

Detailed description

This will be a 4-week multicenter investigator-initiated study, in which a maximum of 200 subjects will be enrolled. As many as two thirds of patients undergoing cataract surgery have dry eye. Often this latter condition is under treated i.e., any dry eye treatment such as artificial tears, that is being pursued in not adequately controlling the visually significant ocular surface disruption, and patient still have corneal staining or a reduced tear break-up time (TBUT). The investigators hypothesize that lifitegrast administered at least 4-week prior to pre-operative biometry measurements will improve both the quality of measurements used to choose an intraocular lens implant for surgery and the symptoms of patients with this combination of conditions. This finding would suggest that pre-treatment with lifitegrast can improve both the accuracy of surgery and patient comfort.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Lifitegrast	Lifitegrast ophthalmic solution 5%

Timeline

• Start date: 2018-12-20
• Primary completion: 2019-10-29
• Completion: 2019-10-29
• First posted: 2019-03-07
• Last updated: 2020-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study