Acute Comfort and Blur Profile of a Lubricant Eye Drop Ve... | NCT01077011

Studies
Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel

NCT01077011

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 21, 2016Estimated

Enrollment

25Actual

Phase

Not Applicable

Conditions

Dry Eye

Interventions

Lubricant eye drop FID 115958D
GenTeal Gel

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

Jan 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

Jan 2010

Primary Completion Date

Jan 2010Actual

Completion Date

Not provided

First Submitted Date

Feb 18, 2010

First Submission Date that Met QC Criteria

Feb 25, 2010

First Posted Date

Feb 26, 2010Estimated

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 21, 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 purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lubricant eye drop	Experimental	Lubricant eye drop	Other: Lubricant eye drop FID 115958D
GenTeal Gel	Active Comparator	GenTeal Gel	Other: GenTeal Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lubricant eye drop FID 115958D	Other	1 drop in each eye, one time	Lubricant eye drop

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Three-minute visual blur profile		Through 3 minutes (post-instillation)
Overall Acceptability		Immediately upon instillation

Secondary Outcomes

Measure	Description	Time Frame
Drop Comfort Upon Instillation		Immediately upon installation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of dry eye

Exclusion Criteria:

Must not have worn contact lenses within 12 hours preceding enrollment
Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

Accepts Healthy Volunteers

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	http://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases