Contact Lenses and Infiltrative Keratitis (CLIK)

July 8, 2016 updated by: Kathryn Richdale, State University of New York College of Optometry
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10036
        • SUNY College of Optometry, Clinical Vision Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tear protein levels
Time Frame: After 4-6 hours of daily wear and after one night extended wear
After 4-6 hours of daily wear and after one night extended wear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York College of Optometry

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIK_601933

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Keratitis

Clinical Trials on senofilcon A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe