Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Tear Supplements on Contact Lens Comfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956083
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Meibomian Gland Dysfunction Other: Systane Balance eye drops Other: Systane Contacts eye drops Other: saline Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Tear Supplements on Contact Lens Comfort
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Tears

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




Primary Outcome Measures :
  1. Contact Lens Discomfort Questionnaire [ Time Frame: 1 months ]
    CLDEQ Questionnaire will be used to quantify contact lens discomfort


Secondary Outcome Measures :
  1. Fluorescein tear break-up time [ Time Frame: 1 month ]
    Fluorescein will be instilled in the conjunctival sac to assess tear break-up time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956083


Sponsors and Collaborators
University of the Incarnate Word
Investigators
Layout table for investigator information
Principal Investigator: Srihari Narayanan, OD, PhD University of the Incarnate Word

Layout table for additonal information
Responsible Party: University of the Incarnate Word
ClinicalTrials.gov Identifier: NCT02956083     History of Changes
Other Study ID Numbers: 14-04-013
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions