The Effect of Tear Supplements on Contact Lens Comfort

Dry Eye Syndromes Clinical Trial

Official title:

The Effect of Tear Supplements on Contact Lens Comfort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956083
• Other study ID #: 14-04-013
• Status: Completed
• Phase: N/A
• First received: November 1, 2016
• Last updated: November 2, 2016
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2016
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Other:
• Systane Balance eye drops
Propylene Glycol 0.6% Over the counter lipid based artificial tears.
• Systane Contacts eye drops
Hydroxypropyl methycellulose over the counter non-lipid based artificial tears
• saline
Saline - no brand name

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of the Incarnate Word

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contact Lens Discomfort Questionnaire	CLDEQ Questionnaire will be used to quantify contact lens discomfort	1 months	No
Secondary	Fluorescein tear break-up time	Fluorescein will be instilled in the conjunctival sac to assess tear break-up time	1 month	No