NCT04172961

Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days

A Phase 4 Study to Assess the Clinical Efficacy of Nanomicellular Cyclosporine 0.09% Versus Lifitegrast 5.0% for Central Corneal Stain Clearing Over 90 Days

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Toyos Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery.

Detailed description

The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	nanomicellular cyclosporine 0.09%	topical ophthalmic drop prior to elective surgery for eligible patients
DRUG	Lifitegrast	topical ophthalmic drop prior to elective surgery for eligible patients

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-11-21
• Last updated: 2022-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study