The Effect of Punctal Plugs on Tear Volume and Osmolality

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372034
• Other study ID #: VRRP2005-018
• Status: Completed
• Phase: N/A
• First received: September 3, 2006
• Last updated: April 6, 2009
• Start date: July 2006
• Est. completion date: March 2007

Study information

• Verified date: April 2009
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Temporary Collagen Inserts

Locations

Country	Name	City	State
Australia	Vision CRC, Institute for Eye Research, School of Optometry and Vision Science	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular comfort after 6 hours of contact lens wear
Primary	Dryness sensation after 6 hours of contact lens wear
Primary	Tear film volume before and after 6 hours of contact lens wear
Secondary	Objective ocular sensitivity after 6 hours of contact lens wear
Secondary	Tear film and contact lens osmolality after 6 hours of contact lens wear