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Trial record 5 of 603 for:    "keratitis-ichthyosis-deafness syndrome" OR "Keratitis"

Contact Lenses and Infiltrative Keratitis (CLIK)

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ClinicalTrials.gov Identifier: NCT02186431
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Kathryn Richdale, State University of New York College of Optometry

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
Keratitis Device: senofilcon A Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : July 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Tears

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 Name: 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 Name: Acuvue Oasys




Primary Outcome Measures :
  1. Tear protein levels [ Time Frame: After 4-6 hours of daily wear and after one night extended wear ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02186431


Locations
United States, New York
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

Additional Information:
Responsible Party: Kathryn Richdale, Assistant Professor, State University of New York College of Optometry
ClinicalTrials.gov Identifier: NCT02186431     History of Changes
Other Study ID Numbers: CLIK_601933
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Kathryn Richdale, State University of New York College of Optometry:
Contact lenses

Additional relevant MeSH terms:
Keratitis
Corneal Diseases
Eye Diseases