Evaluate the Ability of Systane Ultra to Improve Subjecti... | NCT00938951

Studies
Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.

NCT00938951

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Feb 9, 2012Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Dry Eye Symptoms
Visual Performance

Interventions

Systane® Ultra

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

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

Jun 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Not provided

First Submitted Date

Jul 13, 2009

First Submission Date that Met QC Criteria

Jul 13, 2009

First Posted Date

Jul 14, 2009Estimated

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

Feb 8, 2012

Last Update Posted Date

Feb 9, 2012Estimated

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 primary objective of this study is to compare visual degradation in a stressed (forced stare) environment in patients before and after acute administration of Systane Ultra.

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systane® Ultra	Experimental	Systane® Ultra	Other: Systane® Ultra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systane® Ultra	Other	Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%	Systane® Ultra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness of eye drop basd on athlete's opinion/experience during a one hour practice session		60 minutes post-dosing with test article

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Player/ Coach must answer "Yes" to the survey eligibility question.
Player/Coach must voluntarily agree to participate in survey

Exclusion Criteria:

None.

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

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided