The Effect of Tear Supplements on Contact Lens Comfort

Not Applicable

Completed

• Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction
• Interventions: Other: Systane Contacts eye drops; Other: saline; Other: Systane Balance eye drops

• Registration Number: NCT02956083
• Lead Sponsor: University of the Incarnate Word

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-11
• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-02
• Last Update Submitted: 2016-11-02
• Study First Posted: 2016-11-04
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-lipid based artificial tears	Systane Contacts eye drops	patients use non-lipid based artificial tears
Saline	saline	patients use saline
Lipid based artificial tears	Systane Balance eye drops	Patients use lipid based artificial tears

Primary Outcome Measures

Name	Time	Method
Contact Lens Discomfort Questionnaire	1 months	CLDEQ Questionnaire will be used to quantify contact lens discomfort

Secondary Outcome Measures

Name	Time	Method
Fluorescein tear break-up time	1 month	Fluorescein will be instilled in the conjunctival sac to assess tear break-up time