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Safety of Overnight Corneal Reshaping Lenses

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ClinicalTrials.gov Identifier: NCT01272271
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : January 7, 2011
Sponsor:
Collaborators:
Bausch & Lomb Incorporated
Paragon Vision Sciences
Information provided by:
Ohio State University

Brief Summary:
This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.

Condition or disease
Keratitis Myopia

Study Type : Observational
Actual Enrollment : 1317 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Postmarket Study of the Safety of Overnight Corneal Reshaping Lenses
Study Start Date : February 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Children
Adults



Primary Outcome Measures :
  1. Microbial keratitis incidence [ Time Frame: 1 year ]
    Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Randomized sample of optometry and ophthalmology patients seen by 200 practitioners in various practice settings, stratified on manufacturer, practitioner volume.
Criteria

Inclusion Criteria:

  • Patients completing at least 3 months of wearing corneal reshaping lenses

Exclusion Criteria:

  • Less than 3 months of wearing corneal reshaping lenses

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): NCT01272271


Sponsors and Collaborators
Ohio State University
Bausch & Lomb Incorporated
Paragon Vision Sciences
Investigators
Principal Investigator: Mark A Bullimore, PhD Ohio State University

Responsible Party: Mark A. Bullimore, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01272271     History of Changes
Other Study ID Numbers: 2007H0273
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: January 2011

Keywords provided by Ohio State University:
Contact lens
Infection
Cornea

Additional relevant MeSH terms:
Keratitis
Corneal Diseases
Eye Diseases