NCT02956083

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 1, 2016

Last Update Submit

November 2, 2016

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Contact Lens Discomfort Questionnaire

    CLDEQ Questionnaire will be used to quantify contact lens discomfort

    1 months

Secondary Outcomes (1)

  • Fluorescein tear break-up time

    1 month

Study Arms (3)

Lipid based artificial tears

ACTIVE COMPARATOR

Patients use lipid based artificial tears

Other: Systane Balance eye drops

Non-lipid based artificial tears

ACTIVE COMPARATOR

patients use non-lipid based artificial tears

Other: Systane Contacts eye drops

Saline

PLACEBO COMPARATOR

patients use saline

Other: saline

Interventions

Systane Balance eye dropsOTHER

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

Lipid based artificial tears
Systane Contacts eye dropsOTHER

Hydroxypropyl methycellulose over the counter non-lipid based artificial tears

Non-lipid based artificial tears
salineOTHER

Saline - no brand name

Saline

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients complaining of contact lens associated discomfort

You may not qualify if:

  • Patients who do not have contact lens discomfort; patients who have active inflammation or infection of the anterior segment of the eyes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Srihari Narayanan, OD, PhD

    University of the Incarnate Word

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 4, 2016

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 4, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share