Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-13 @ 11:25 AM
Study NCT ID:
NCT04172961
Status:
UNKNOWN
Last Update Posted:
2022-10-20
First Post:
2019-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days
Sponsor:
Toyos Clinic
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: