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NCT01272271 Clinical Trial

Safety of Overnight Corneal Reshaping Lenses

Myopia Clinical Trial

Official title:
Postmarket Study of the Safety of Overnight Corneal Reshaping Lenses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01272271
Other study ID # 2007H0273
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2008
Est. completion date October 2010

Study information
Verified date April 2024
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1317
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 69 Years
Eligibility Inclusion Criteria: - Patients completing at least 3 months of wearing corneal reshaping lenses Exclusion Criteria: - Less than 3 months of wearing corneal reshaping lenses

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Ohio State University Bausch & Lomb Incorporated, Coopervision, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Microbial keratitis incidence Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses. 1 year
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