An Evaluation of a Marketed Lubricated Eye Drop in Soft C... | NCT01132287

Studies
An Evaluation of a Marketed Lubricated Eye Drop in Soft Contact Lens Wearers Who Experience Ocular Dryness

NCT01132287

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 21, 2016Estimated

Enrollment

92Actual

Phase

Not Applicable

Conditions

Contact Lens Wear

Interventions

FID 112903

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

Apr 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

May 26, 2010

First Submission Date that Met QC Criteria

May 27, 2010

First Posted Date

May 28, 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

Study to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

Detailed Description

The objective of this study is to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

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

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 FID 112903	Experimental	FID 112903	Other: FID 112903
No Intervention	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FID 112903	Other	lubricant eye drop FID 112903	1 FID 112903	Systane Ultra

Measure	Description	Time Frame
Subjective Comfort		14 days

Measure	Description	Time Frame
Slit Lamp		14 Days
Visual Acuity		14 Days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal eyes

Exclusion Criteria:

Topical ocular medication use Unstable or active ocular issues

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24552755	Result	McDonald M, Schachet JL, Lievens CW, Kern JR. Systane(R) ultra lubricant eye drops for treatment of contact lens-related dryness. Eye Contact Lens. 2014 Mar;40(2):106-10. doi: 10.1097/ICL.0000000000000018.