The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)

August 27, 2021 updated by: Eric R. Ritchey, University of Houston
This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary study objectives are to determine the amount of Lid Wiper Epitheliopathy (LWE) induced in subjects after contact lens fitting that do not have LWE at study enrollment. Subjects in the trial will be fit in 2 contact lenses with different coefficients of friction (CoF). One eye will be fit in a contact lens with a low coefficient of friction (Acuvue Oasys®, Johnson & Johnson Vision, Jacksonville FL) while the contralateral eye will be fit in a contact lens with a high CoF (Air Optix® Night & Day® Aqua, Ft. Worth, TX), as reported in the scientific literature. The eye receiving each lens will be assigned randomly. The presence of LWE will be assessed at 2 different time points, approximately 2 hours after contact lens fitting and approximately after 7 days of contact lens wear.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • The Ocular Surface Institute, The University of Houston College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must be able to read and understand the study informed consent
  2. Must be a minimum of 18 years of age and less than 46 years of age at study enrollment
  3. Must be healthy non-soft contact lens wearers (neophytes), or experienced contact lens wearers that have not worn their contact lenses for a minimum of 7 days
  4. Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle plane
  5. The subject must be able to attend study visits at the prescribed visit times and adhere to the study instructions

Exclusion Criteria:

  1. Pregnant and/or lactating females by self-report
  2. Presence of current LWE on the upper eyelid (>0.5 in height or width)
  3. Has greater than -1.00DC of refractive cylinder
  4. Has greater than 1.00D of anisometropia
  5. Is aphakic
  6. Has clinically significant corneal or conjunctival staining that would prevent contact lens fitting, as assessed with sodium fluorescein dye
  7. Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-Johnson Syndrome, etc.) or significant Dry Eye Syndrome
  8. Has clinically significant corneal vascularization or central corneal scaring
  9. Has active ocular surface infection (e.g. conjunctivitis)
  10. Has a positive history of eyelid surgery or trauma
  11. Has a positive history of refractive surgery
  12. Takes medications that significantly impact contact lens comfort and/or ocular surface health
  13. Has taken part in another contact lens or contact lens solution clinical trial within the last 7 days
  14. Is unwilling to have eyes photographed or video recorded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Eye 1: Low coefficient of friction
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 1 will be fit in a contact lens with a low coefficient of friction, Acuvue Oasys.
Device: Acuvue Oasys
FDA approved contact lens, fit for daily wear
Other: Eye 2: High coefficient of friction
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 2 One eye will be fit in a contact lens with a high coefficient of friction, Air Optix Night & Day Aqua
Device: Air Optix Night & Day Aqua
FDA approved contact lens, fit for daily wear

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lid Wiper Epitheliopathy
Time Frame: One week post contact lens fitting
Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy.
One week post contact lens fitting

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lid Wiper Epitheliopathy
Time Frame: 2 hours post contact lens fitting
Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy.
2 hours post contact lens fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric R Ritchey, OD, PhD, University of Houston
  • Principal Investigator: Rachel Redfern, OD, PhD, University of Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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