Safety of Overnight Corneal Reshaping Lenses | NCT01272271

Studies
Safety of Overnight Corneal Reshaping Lenses

NCT01272271

Sponsor

Ohio State University

Status

Completed

Last Update Posted

Apr 29, 2024Actual

Enrollment

1,317Actual

Phase

Not provided

Conditions

Keratitis
Myopia

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jan 6, 2011

First Submission Date that Met QC Criteria

Jan 6, 2011

First Posted Date

Jan 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2024

Last Update Posted Date

Apr 29, 2024Actual

Name	Class
Bausch & Lomb Incorporated	INDUSTRY
CooperVision, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,317Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microbial keratitis incidence	Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

69 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Randomized sample of optometry and ophthalmology patients seen by 200 practitioners in various practice settings, stratified on manufacturer, practitioner volume.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark A Bullimore, PhD	Ohio State University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007634	Keratitis
D009216	Myopia
D007239	Infections
D003316	Corneal Diseases

Ancestor Terms

ID	Term
D005128	Eye Diseases
D012030	Refractive Errors

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Children
Adults