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The Effect of Tear Supplements on Contact Lens Comfort

NCT ID: NCT02956083

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-07-31

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.

Conditions

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Dry Eye Syndromes Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lipid based artificial tears

Patients use lipid based artificial tears

Group Type ACTIVE_COMPARATOR

Systane Balance eye drops

Intervention Type OTHER

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

Non-lipid based artificial tears

patients use non-lipid based artificial tears

Group Type ACTIVE_COMPARATOR

Systane Contacts eye drops

Intervention Type OTHER

Hydroxypropyl methycellulose over the counter non-lipid based artificial tears

Saline

patients use saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

Saline - no brand name

Interventions

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Systane Balance eye drops

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

Intervention Type OTHER

Systane Contacts eye drops

Hydroxypropyl methycellulose over the counter non-lipid based artificial tears

Intervention Type OTHER

saline

Saline - no brand name

Intervention Type OTHER

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Incarnate Word

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Srihari Narayanan, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Incarnate Word

Other Identifiers

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14-04-013

Identifier Type: -

Identifier Source: org_study_id