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CLIK: Contact Lenses and Infiltrative Keratitis

Sponsor
State University of New York College of Optometry (Other)
Overall Status
Completed
CT.gov ID
NCT02186431
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
22
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events, to those without a history of complications. This will be accomplished via measurement of select anti-inflammatory tear proteins before, during and after contact lens wear.

Condition or Disease Intervention/Treatment Phase
  • Device: senofilcon A
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Contact Lenses and Infiltrative Keratitis
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: history of corneal infiltrative events

To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events

Device: senofilcon A
Other Names:
  • Acuvue Oasys

    		•
    Active Comparator: without a history of corneal infiltrative events

    To quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events.

    Device: senofilcon A
    Other Names:
  • Acuvue Oasys

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tear protein levels [After 4-6 hours of daily wear and after one night extended wear]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Soft contact lens wearers

    • Healthy (control), or with history of infiltrative keratitis (case)

    • Has a wearable pair of glasses

    • Refractive error between +8.00 D and -12.00 D, with less than 1.50 D of astigmatism

    Exclusion Criteria:

    • Smoker

    • Pregnant or nursing

    • Systemic disease that would effect tear proteins

    • Punctal plugs

    • Use of eye drops in the last week

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SUNY College of Optometry, Clinical Vision Research Center New York New York United States 10036

    Sponsors and Collaborators

    • State University of New York College of Optometry

    Investigators

    • Principal Investigator: Kathryn Richdale, OD, PhD, State University of New York College of Optometry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kathryn Richdale, Assistant Professor, State University of New York College of Optometry
    ClinicalTrials.gov Identifier:
    NCT02186431
    Other Study ID Numbers:
    • CLIK_601933
    First Posted:
    Jul 10, 2014
    Last Update Posted:
    Jul 12, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Kathryn Richdale, Assistant Professor, State University of New York College of Optometry
    Contact lenses
    Additional relevant MeSH terms:
    Keratitis

    Study Results

    No Results Posted as of Jul 12, 2016