NCT03686878

Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

Safety and Efficacy of Lifitegrast 5% Ophthalmic Solution in Contact Lens Discomfort

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: EV Clinical Trials · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The most common reason for contact lens discontinuation is contact lens discomfort. The investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. This study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.

Detailed description

Contact lens discontinuation is mostly associated with ocular discomfort. Most patients identifying dryness as the primary reason for contact lens discontinuation. Patients often resort to contact lens solutions, lubricating and/or rewetting drops to temporality improve their contact lens wearing experience. Clinicians often resort to changing contact lens designs, solutions and wearing modalities to improve comfort. Contact lens discomfort is believed to be mediated by many factors including inflammation and very similar in clinical symptoms of dry eye disease and symptoms of dryness. Lifitegrast 5.0% ophthalmic solution is an FDA approved solution for the management of signs and symptoms of dryness of dry eye disease. Studies have shown lifitegrast 5% ophthalmic solution may work by blocking the interaction between ICAM-1 and LFA-1 leading to a decrease in activation and recruitment of T-cells, an initial step in inflammation. The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients for signs (https://www.xiidra-ecp.com/efficacy-treating-signs) and symptoms (https://www.xiidra-ecp.com/efficacy-symptom-improvement). The purpose of this open label, interventional study is to examine the effect of lifitegrast 5% ophthalmic solution in contact lens wearing experience by using the CLDEQ-8.

Conditions

• Contact Lens
• Contact Lens Discomfort
• Contact Lens Dryness

Interventions

Type	Name	Description
DRUG	Lifitegrast	Lifitegrast used twice a day

Timeline

• Start date: 2016-12-16
• Primary completion: 2017-07-14
• Completion: 2017-07-14
• First posted: 2018-09-27
• Last updated: 2018-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study