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The Effect of Punctal Plugs on Tear Volume and Osmolality

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Temporary Collagen Inserts
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring contact lenses, intolerance, punctal plugs, tear volume, Intolerance to contact lens wear due to dryness symptoms

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vision CRC, Institute for Eye Research, School of Optometry and Vision Science

Outcomes

Primary Outcome Measures

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 Outcome Measures

Objective ocular sensitivity after 6 hours of contact lens wear
Tear film and contact lens osmolality after 6 hours of contact lens wear

Full Information

First Posted
September 3, 2006
Last Updated
April 6, 2009
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT00372034
Brief Title
The Effect of Punctal Plugs on Tear Volume and Osmolality
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of New South Wales

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
contact lenses, intolerance, punctal plugs, tear volume, Intolerance to contact lens wear due to dryness symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Temporary Collagen Inserts
Primary Outcome Measure Information:
Title
Ocular comfort after 6 hours of contact lens wear
Title
Dryness sensation after 6 hours of contact lens wear
Title
Tear film volume before and after 6 hours of contact lens wear
Secondary Outcome Measure Information:
Title
Objective ocular sensitivity after 6 hours of contact lens wear
Title
Tear film and contact lens osmolality after 6 hours of contact lens wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Stahl, Dipl-Optom
Organizational Affiliation
VisionCRC, School of Optometry and Vision Science, Institute for Eye Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vision CRC, Institute for Eye Research, School of Optometry and Vision Science
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2033
Country
Australia

12. IPD Sharing Statement

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The Effect of Punctal Plugs on Tear Volume and Osmolality

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