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The Effect of Punctal Plugs on Tear Volume and Osmolality

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The University of New South Wales

Status

Completed

Conditions

Dry Eye Syndromes

Treatments

Device: Temporary Collagen Inserts

Study type

Interventional

Funder types

Other

Identifiers

NCT00372034
VRRP2005-018

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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