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NCT02186431 Clinical Trial

Contact Lenses and Infiltrative Keratitis

Keratitis Clinical Trial

— CLIK  

Official title:
Contact Lenses and Infiltrative Keratitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02186431
Other study ID # CLIK_601933
Secondary ID
Status Completed
Phase N/A
First received July 7, 2014
Last updated July 8, 2016
Start date July 2014
Est. completion date May 2016

Study information
Verified date July 2016
Source State University of New York College of Optometry
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• senofilcon A

Locations
Country Name City State
United States SUNY College of Optometry, Clinical Vision Research Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
State University of New York College of Optometry

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tear protein levels After 4-6 hours of daily wear and after one night extended wear No
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