NCT04792580

The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease

A Single-Center Randomized Double-Masked Placebo-Controlled Parallel-Group, Study of the Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Richard W Yee, MD · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the clinical efficacy of 5% lifitegrast ophthalmic solution in subjects with dry eye disease secondary to ocular Graft-versus-Host Disease compared to placebo.

Conditions

• Graft-versus-host-disease
• Ocular Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Lifitegrast 5% Ophthalmic Solution	Used twice a day in both eyes for 4 weeks after a 2 week washout.
DRUG	Placebo	Used twice a day in both eyes for 4 weeks after a 2 week washout with the same drops.

Timeline

• Start date: 2022-10-22
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2021-03-11
• Last updated: 2024-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study