Fluorophotometry Evaluation of Lubricant Eye Drops | NCT00347854

Studies
Fluorophotometry Evaluation of Lubricant Eye Drops

NCT00347854

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 22, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Systane Free lubricant eye drops
Visine Tears Lubricant Eye Drops
Refresh Liquigel Lubricant Eye Drops
Refresh Plus Lubricant Eye Drops

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

Feb 2012

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

Apr 2006

Primary Completion Date

Apr 2006Actual

Completion Date

Apr 2006Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jul 3, 2006

First Posted Date

Jul 4, 2006Estimated

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

Nov 18, 2016

Last Update Posted Date

Nov 22, 2016Estimated

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

The objective of this study is to evaluate the safety and efficacy of exaggerated use of Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial permeability to fluorescein.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
FID 105783	Experimental	Other: Systane Free lubricant eye drops
Visine	Active Comparator	Other: Visine Tears Lubricant Eye Drops
Refresh Liquigel	Active Comparator	Other: Refresh Liquigel Lubricant Eye Drops
Refresh Plus	Active Comparator	Other: Refresh Plus Lubricant Eye Drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systane Free lubricant eye drops	Other		FID 105783
Visine Tears Lubricant Eye Drops

Measure	Description	Time Frame
Epithelial permeability to fluorescein

Measure	Description	Time Frame
tear turnover rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18 and over

Exclusion Criteria:

No sodium fluorescein corneal staining at Screening Visit

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mike Christensen	Alcon Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alcon		Fort Worth	Texas	76134	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	http://www.aaopt.org/evaluation-new-preservation-system-corneal-barrier-function

ID	Term
D009883	Ophthalmic Solutions
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations