Contact Lenses and Infiltrative Keratitis | NCT02186431

Studies
Contact Lenses and Infiltrative Keratitis

NCT02186431

Sponsor

State University of New York College of Optometry

Status

Completed

Last Update Posted

Jul 12, 2016Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Keratitis

Interventions

senofilcon A

Countries

United States

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

Jul 2016

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

Jul 2014

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jul 7, 2014

First Submission Date that Met QC Criteria

Jul 7, 2014

First Posted Date

Jul 10, 2014Estimated

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

Jul 8, 2016

Last Update Posted Date

Jul 12, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kathryn Richdale, Assistant Professor, State University of New York College of OptometryPrincipal Investigator

Lead Sponsor

State University of New York College of OptometryOTHER

Collaborators

Not provided

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

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
history of corneal infiltrative events	Experimental	To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events	Device: senofilcon A
without a history of corneal infiltrative events	Active Comparator	To quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events.	Device: senofilcon A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
senofilcon A	Device		history of corneal infiltrative events without a history of corneal infiltrative events	Acuvue Oasys

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathryn Richdale, OD, PhD	State University of New York College of Optometry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY College of Optometry, Clinical Vision Research Center		New York	New York	10036	United States

Condition Browse Module

MeSH Terms

ID	Term
D007634	Keratitis

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided