Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT01870856
Status:
TERMINATED
Last Update Posted:
2014-10-29
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lid Wiper Epitheliopathy Trial
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary efficacy was not demonstrated in Stage 1
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.
Detailed Description:
This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: