Back to resultsContact Lenses and Infiltrative Keratitis (CLIK)
Primary Purpose
Keratitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
senofilcon A
Sponsored by
About this trial
This is an interventional diagnostic trial for Keratitis focused on measuring Contact lenses
Eligibility Criteria
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
Sites / Locations
- SUNY College of Optometry, Clinical Vision Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
history of corneal infiltrative events
without a history of corneal infiltrative events
Arm Description
To quantify and compare baseline tear proteins and ocular response in contact lens wearers with 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.
Outcomes
Primary Outcome Measures
Tear protein levels
Secondary Outcome Measures
Full Information
NCT ID
NCT02186431
First Posted
July 7, 2014
Last Updated
July 8, 2016
Sponsor
State University of New York College of Optometry
1. Study Identification
Unique Protocol Identification Number
NCT02186431
Brief Title
Contact Lenses and Infiltrative Keratitis
Acronym
CLIK
Official Title
Contact Lenses and Infiltrative Keratitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York College of Optometry
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis
Keywords
Contact lenses
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
history of corneal infiltrative events
Arm Type
Experimental
Arm Description
To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events
Arm Title
without a history of corneal infiltrative events
Arm Type
Active Comparator
Arm Description
To quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events.
Intervention Type
Device
Intervention Name(s)
senofilcon A
Other Intervention Name(s)
Acuvue Oasys
Primary Outcome Measure Information:
Title
Tear protein levels
Time Frame
After 4-6 hours of daily wear and after one night extended wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Richdale, OD, PhD
Organizational Affiliation
State University of New York College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY College of Optometry, Clinical Vision Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Contact Lenses and Infiltrative Keratitis
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