The Effect of Tear Supplements on Contact Lens Comfort

• Sponsor: University of the Incarnate Word (Other)
• Overall Status: Completed
• CT.gov ID: NCT02956083
• Collaborator: (none)
• Enrollment: 30
• Arms: 3
• Duration (Months): 12

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jul 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Contact Lens Discomfort Questionnaire [1 months]

   CLDEQ Questionnaire will be used to quantify contact lens discomfort

Secondary Outcome Measures

1. Fluorescein tear break-up time [1 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of the Incarnate Word

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of the Incarnate Word
• ClinicalTrials.gov Identifier: NCT02956083
• Other Study ID Numbers: 14-04-013
• First Posted: Nov 4, 2016
• Last Update Posted: Nov 4, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Meibomian Gland Dysfunction; Ophthalmic Solutions

Study Results

No Results Posted as of Nov 4, 2016