The Effect of Punctal Plugs on Tear Volume and Osmolality
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00372034|
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : April 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Device: Temporary Collagen Inserts||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
- 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
- Objective ocular sensitivity after 6 hours of contact lens wear
- Tear film and contact lens osmolality after 6 hours of contact lens wear
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372034
|Australia, New South Wales|
|Vision CRC, Institute for Eye Research, School of Optometry and Vision Science|
|Sydney, New South Wales, Australia, 2033|
|Principal Investigator:||Ulrike Stahl, Dipl-Optom||VisionCRC, School of Optometry and Vision Science, Institute for Eye Research|