The Effect of Punctal Plugs on Tear Volume and Osmolality | NCT00372034

Studies
The Effect of Punctal Plugs on Tear Volume and Osmolality

NCT00372034

Sponsor

The University of New South Wales

Status

Completed

Last Update Posted

Apr 7, 2009Estimated

Enrollment

Phase

Not Applicable

Conditions

Dry Eye Syndromes

Interventions

Temporary Collagen Inserts

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Sep 3, 2006

First Submission Date that Met QC Criteria

Sep 5, 2006

First Posted Date

Sep 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2009

Last Update Posted Date

Apr 7, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The University of New South WalesOTHER

Collaborators

Not provided

Description Module

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 dryness/discomfort 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Temporary Collagen Inserts	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular comfort after 6 hours of contact lens wear
Dryness sensation after 6 hours of contact lens wear
Tear film volume before and after 6 hours of contact lens wear

Secondary Outcomes

Measure	Description	Time Frame
Objective ocular sensitivity after 6 hours of contact lens wear
Tear film and contact lens osmolality after 6 hours of contact lens wear

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years of age

Exclusion Criteria:

Corneal refractive surgery
Contraindications to contact lens wear
Latex allergy
Corneal hypoesthesia
Active corneal infection
Acute or sub-acute inflammation or infection of the anterior chamber of the eye

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrike Stahl, Dipl-Optom	VisionCRC, School of Optometry and Vision Science, Institute for Eye Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vision CRC, Institute for Eye Research, School of Optometry and Vision Science		Sydney	New South Wales	2033	Australia

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided