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Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ZenLens
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Scleral Contact Lens, Tear Proteases, Tear Cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Had been diagnosed with keratoconus in at least one eye.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.

Exclusion Criteria:

  • Is using any topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
  • Is aphakic.
  • Has undergone any corneal surgery.
  • Is participating in any other type of eye related clinical or research study.
  • Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ZenLens with Low limbal clearance

    ZenLens with High limbal clearance

    Arm Description

    Scleral contact lens designed to provide approximately 25 microns of limbal clearance.

    Scleral contact lens designed to provide approximately 80 microns of limbal clearance.

    Outcomes

    Primary Outcome Measures

    Tear Protein
    To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL).

    Secondary Outcome Measures

    Comfort
    Participants will be asked to rate their ocular comfort, dryness, burning and vision with the contact lenses.
    Bulbar and limbal hyperemia
    The eyes of the participants will be imaged using the Keratograph® 5.
    Corneal thickness
    Their corneal thickness will be measured with the Visante OCT.

    Full Information

    First Posted
    June 16, 2016
    Last Updated
    June 25, 2019
    Sponsor
    University of Waterloo
    Collaborators
    Bausch & Lomb Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02806921
    Brief Title
    Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes
    Official Title
    Protease and Cytokine Composition in Post Lens Tear Reservoir of Scleral Lenses for Keratoconic Eyes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    January 30, 2018 (Actual)
    Study Completion Date
    February 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Waterloo
    Collaborators
    Bausch & Lomb Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.
    Detailed Description
    Scleral contact lenses are rigid gas permeable lenses designed to rest on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses has become the current standard of practice as a nonsurgical management of corneal ectasia and ocular surface diseases. Cases have been recently presented of scleral lens wearers exhibiting adverse corneal findings and conjunctival injection from lens wear. These findings are likely associated with the mechanical and hypoxic effects due to poor fitting characteristics at the limbal area. Tear film analysis detecting changes in the levels of proteinases and cytokines have helped researchers gain a better understanding of the pathophysiology of complications in soft contact lenses wearers, dry eye, and keratoconus. Ultimately, this study will provide insights in relating scleral lens fitting characteristics and corneal and limbal physiological responses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus
    Keywords
    Scleral Contact Lens, Tear Proteases, Tear Cytokines

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ZenLens with Low limbal clearance
    Arm Type
    Active Comparator
    Arm Description
    Scleral contact lens designed to provide approximately 25 microns of limbal clearance.
    Arm Title
    ZenLens with High limbal clearance
    Arm Type
    Active Comparator
    Arm Description
    Scleral contact lens designed to provide approximately 80 microns of limbal clearance.
    Intervention Type
    Device
    Intervention Name(s)
    ZenLens
    Intervention Description
    The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
    Primary Outcome Measure Information:
    Title
    Tear Protein
    Description
    To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL).
    Time Frame
    2 weeks of lens wear with daily schedule of 6-8 hours.
    Secondary Outcome Measure Information:
    Title
    Comfort
    Description
    Participants will be asked to rate their ocular comfort, dryness, burning and vision with the contact lenses.
    Time Frame
    2 weeks of lens wear with daily schedule of 6-8 hours.
    Title
    Bulbar and limbal hyperemia
    Description
    The eyes of the participants will be imaged using the Keratograph® 5.
    Time Frame
    2 weeks of lens wear with daily schedule of 6-8 hours.
    Title
    Corneal thickness
    Description
    Their corneal thickness will be measured with the Visante OCT.
    Time Frame
    2 weeks of lens wear with daily schedule of 6-8 hours.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Had been diagnosed with keratoconus in at least one eye. Is at least 18 years of age and has full legal capacity to volunteer. Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Exclusion Criteria: Is using any topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses. Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. Has any clinically significant lid or conjunctival abnormalities and active neovascularization. Is aphakic. Has undergone any corneal surgery. Is participating in any other type of eye related clinical or research study. Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes

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