NCT04669561

The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study

The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study: An Investigation on Lifitegrast's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Research Insight LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In patients with dry eye, defined as corneal staining and a reduced tear breakup time, lifitegrast will improve higher order aberrations, ocular scatter index, corneal staining, and TBUT as soon as 1 week after initiating treatment.

Detailed description

This is a multicenter, prospective, open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Lifitegrast 5% Ophthalmic Solution	Open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days.

Timeline

• Start date: 2021-03-17
• Primary completion: 2021-08-31
• Completion: 2021-10-08
• First posted: 2020-12-17
• Last updated: 2021-10-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study