The Effect of Tear Supplements on Contact Lens Comfort

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02956083

Enrollment

Registered

2016-11-04

Start date

2014-07-31

Completion date

2015-07-31

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Meibomian Gland Dysfunction

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).

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.

Interventions

OTHERSystane Balance eye drops

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

OTHERSystane Contacts eye drops

Hydroxypropyl methycellulose over the counter non-lipid based artificial tears

OTHERsaline

Saline - no brand name

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Contact Lens Discomfort Questionnaire	1 months	CLDEQ Questionnaire will be used to quantify contact lens discomfort

Secondary

Measure	Time frame	Description
Fluorescein tear break-up time	1 month	Fluorescein will be instilled in the conjunctival sac to assess tear break-up time

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026