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The Effect of Punctal Plugs on Tear Volume and Osmolality

This study has been completed.
Sponsor:
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00372034
First received: September 3, 2006
Last updated: April 6, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention
Dry Eye Syndromes
 Device: Temporary Collagen Inserts

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by The University of New South Wales:

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

Estimated Enrollment: 20
Study Start Date: July 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372034

Locations
Australia, New South Wales
Vision CRC, Institute for Eye Research, School of Optometry and Vision Science
Sydney, New South Wales, Australia, 2033
Sponsors and Collaborators
The University of New South Wales
Investigators
Principal Investigator: Ulrike Stahl, Dipl-Optom VisionCRC, School of Optometry and Vision Science, Institute for Eye Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00372034     History of Changes
Other Study ID Numbers: VRRP2005-018
Study First Received: September 3, 2006
Last Updated: April 6, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The University of New South Wales:
contact lenses
intolerance
punctal plugs
tear volume
Intolerance to contact lens wear due to dryness symptoms

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on May 23, 2013