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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209505
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eric R. Ritchey, University of Houston

Brief Summary:
This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF)

Condition or disease Intervention/treatment Phase
Lid Wiper Epitheliopathy Device: Acuvue Oasys Device: Air Optix Night & Day Aqua Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. One eye will be fit in a contact lens with a low coefficient of friction while the contralateral eye will be fit in a contact lens with a high coefficient of friction.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Subjects will be masked to the contact lens brand fit in each eye. The subject's Lid Wiper Epitheliopathy will be graded using photographs of the eyelid, where the grader is masked to the lens type in each eye.
Primary Purpose: Basic Science
Official Title: The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
Actual Study Start Date : June 26, 2017
Actual Primary Completion Date : April 13, 2018
Actual Study Completion Date : April 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Lid Wiper Epitheliopathy [ Time Frame: One week post contact lens fitting ]
    Staining of the eyelid lid wiper (the portion of marginal conjunctiva that comes in contact with ocular surface or contact lens during blinking)


Secondary Outcome Measures :
  1. Lid Wiper Epitheliopathy [ Time Frame: 2 hours post contact lens fitting ]
    Staining of the eyelid lid wiper (the portion of marginal conjunctiva that comes in contact with ocular surface or contact lens during blinking)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209505


Locations
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United States, Texas
The Ocular Surface Institute, The University of Houston College of Optometry
Houston, Texas, United States, 77204
Sponsors and Collaborators
University of Houston
Investigators
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Principal Investigator: Eric R Ritchey, OD, PhD University of Houston
Principal Investigator: Rachel Redfern, OD, PhD University of Houston
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Responsible Party: Eric R. Ritchey, Assistant Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03209505    
Other Study ID Numbers: STUDY00000386
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Eric R. Ritchey, University of Houston:
Lid Wiper Epitheliopahty
Coefficient of Friction