Viewing Study NCT00372034



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Study NCT ID: NCT00372034
Status: COMPLETED
Last Update Posted: 2009-04-07
First Post: 2006-09-03

Brief Title: The Effect of Punctal Plugs on Tear Volume and Osmolality
Sponsor: The University of New South Wales
Organization: The University of New South Wales

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2009-04
Last Known Status: None
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: The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear and the possible influence on osmolality and ocular surface sensitivity
Detailed Description: 50 of contact lens wearers have drynessdiscomfort during contact lens wear Significant decreases in lipid layer and tear film break up time during contact lens wear have been reported leading to excessive evaporation reduced tear volume and an increase in osmolality

Similar tear film changes occur with Dry Eye Disease A commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms Punctal plugs block the tear drainage system and often increase tear stability and improve ocular surface health

This study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear and the possible influence on osmolality and ocular surface sensitivity Collagen punctal plugs will be used for this study as these allow a temporary 3-14 days occlusion of the ocular drainage system are easily removed if necessary and are inserted with minimal risk

Study Oversight

Has Oversight DMC: None
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?: None