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Completed

NCT Number: NCT00372034

The Effect of Punctal Plugs on Tear Volume and Osmolality

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Sydney, New South Wales, 2033, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporary Collagen Inserts

Device

Primary outcomes

  1. Ocular comfort after 6 hours of contact lens wear

  2. Dryness sensation after 6 hours of contact lens wear

  3. Tear film volume before and after 6 hours of contact lens wear

Secondary outcomes

  1. Objective ocular sensitivity after 6 hours of contact lens wear

  2. Tear film and contact lens osmolality after 6 hours of contact lens wear

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 6, 2006
Registry last updated
Apr 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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