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OpenTrials
Completed

NCT Number: NCT02956083

The Effect of Tear Supplements on Contact Lens Comfort

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systane Balance eye drops

Other

Propylene Glycol 0.6% Over the counter lipid based artificial tears.

Systane Contacts eye drops

Other

Hydroxypropyl methycellulose over the counter non-lipid based artificial tears

Saline

Other

Saline - no brand name

Primary outcomes

  1. Contact Lens Discomfort Questionnaire

    Time frame: 1 months

    CLDEQ Questionnaire will be used to quantify contact lens discomfort

Secondary outcomes

  1. Fluorescein tear break-up time

    Time frame: 1 month

    Fluorescein will be instilled in the conjunctival sac to assess tear break-up time

Sponsors and collaborators

Lead sponsor

University of the Incarnate Word

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 4, 2016
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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