The Effect of Punctal Plugs on Tear Volume and Osmolality

• Sponsor: The University of New South Wales (Other)
• Overall Status: Completed
• CT.gov ID: NCT00372034
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Device: Temporary Collagen Inserts	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00372034
• Other Study ID Numbers: VRRP2005-018
• First Posted: Sep 6, 2006
• Last Update Posted: Apr 7, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: contact lenses; intolerance; punctal plugs; tear volume; Intolerance to contact lens wear due to dryness symptoms
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

No Results Posted as of Apr 7, 2009