Efficacy of Systane Balance to Stabilize the Tear Film in... | NCT01086774

Studies
Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

NCT01086774

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Feb 2, 2012Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Dry Eye

Interventions

Systane Ultra Lubricant Eye Drops

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

Jul 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Not provided

First Submitted Date

Mar 12, 2010

First Submission Date that Met QC Criteria

Mar 12, 2010

First Posted Date

Mar 15, 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

Jan 31, 2012

Last Update Posted Date

Feb 2, 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

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systane Ultra	Experimental	Systane Ultra Lubricant Eye Drops	Other: Systane Ultra Lubricant Eye Drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systane Ultra Lubricant Eye Drops	Other	Single drop in both eyes	Systane Ultra

Measure	Description	Time Frame
Improvement in maximum blink interval (MBI)		1 day

Measure	Description	Time Frame
Tear film stability and contrast sensitivity		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or more.
Subjects must have Tear Break Up Time (TBUT) < 5 seconds
Subjects must have a maximum blink interval (MBI) < 10 seconds
Subjects must be willing to comply with all study requirements.
Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
Subjects with known sensitivity to planned study concomitant medications
Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

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