The Effect of Punctal Plugs on Tear Volume and Osmolality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Ocular comfort after 6 hours of contact lens wear
Study Overview
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.
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
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Objective ocular sensitivity after 6 hours of contact lens wear
- Tear film and contact lens osmolality after 6 hours of contact lens wear