The Effect of Tear Supplements on Contact Lens Comfort

Study Overview
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Brief Summary
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The primary goal of this investigation is to determine if lipid based artificial tear supplementation has an impact on contact lens discomfort (CLD).

Detailed Description
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Contact lens discomfort (CLD) is the most common cause of discontinuing contact lens wear. Despite years of research and innovations in technology, CLD remains highly prevalent, and thus it is a major concern for patients and practitioners. Studies suggest that meibomian gland dysfunction (MGD) is a cause of CLD. Several lipid-based artificial tears have recently been designed to address dry eye associated with MGD. In this study, the investigators examine if the benefits of lipid based artificial tears extend to improving contact lens comfort. Studies have demonstrated some usefulness of non-lipid based tear supplements in the management of contact lens discomfort. However, the relief was moderate and short-term. To date, no study has examined the impact of lipid based artificial tears on contact lens discomfort. In this study, the investigators will address this gap in knowledge.

Official Title
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The Effect of Tear Supplements on Contact Lens Comfort

Conditions
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Dry Eye Syndromes, Meibomian Gland Dysfunction

Intervention / Treatment
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* Other: Systane Balance eye drops
* Other: Systane Contacts eye drops
* Other: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients complaining of contact lens associated discomfort Exclusion Criteria: Patients who do not have contact lens discomfort; patients who have active inflammation or infection of the anterior segment of the eyes.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipid based artificial tears<br>Patients use lipid based artificial tears | Other: Systane Balance eye drops<br>* Propylene Glycol 0.6% Over the counter lipid based artificial tears.<br>|
| Active Comparator: Non-lipid based artificial tears<br>patients use non-lipid based artificial tears | Other: Systane Contacts eye drops<br>* Hydroxypropyl methycellulose over the counter non-lipid based artificial tears<br>|
| Placebo Comparator: Saline<br>patients use saline | Other: saline<br>* Saline - no brand name<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Discomfort Questionnaire | CLDEQ Questionnaire will be used to quantify contact lens discomfort | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein tear break-up time | Fluorescein will be instilled in the conjunctival sac to assess tear break-up time | 1 month |