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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction
• Intervention / Treatment: Other: Systane Balance eye drops; Other: Systane Contacts eye drops; Other: saline

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of the Incarnate Word
• Investigators: Principal Investigator: Srihari Narayanan, OD, PhD, University of the Incarnate Word

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Dry Eye Syndromes; Meibomian Gland Dysfunction; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: 14-04-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO